{"id":1022,"date":"2025-12-12T00:51:42","date_gmt":"2025-12-12T00:51:42","guid":{"rendered":"https:\/\/test.geo-tester.com\/?p=1022"},"modified":"2025-12-12T00:52:10","modified_gmt":"2025-12-12T00:52:10","slug":"10-essential-benefits-of-a-reliable-softgel-capsule-hardness-tester","status":"publish","type":"post","link":"https:\/\/test.geo-tester.com\/lt\/resources\/10-essential-benefits-of-a-reliable-softgel-capsule-hardness-tester.html","title":{"rendered":"10 esmini\u0173 patikimo mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo testerio privalum\u0173"},"content":{"rendered":"

Kas yra mink\u0161tasis gelis kapsuli\u0173 kietumas<\/a> testeris? Prie\u0161 pakuojant mink\u0161t\u0105sias \u017eelatinos kapsules reikia atlikti elastingumo bandym\u0105. \u010cia reikalingas ne bet koks testeris, o paprastas testeris.<\/p>\n\n\n\n

Kapsuli\u0173 gamintojams reikia patikimo mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo testerio, kad u\u017etikrint\u0173, jog j\u0173 produktai atitinka nustatytus pramon\u0117s standartus, prie\u0161 i\u0161leisdami produktus vartotojams.<\/p>\n\n\n\n

Rezultatas parodys, ar kapsul\u0117 turi signal\u0105, kad j\u0105 galima pakuoti, ar ne. Taip galima i\u0161vengti pakartotini\u0173 gedim\u0173 pakuojant, kurie gali reik\u0161ti papildomas i\u0161laidas gamintojui.<\/p>\n\n\n\n

\"Gelomat\" siekia u\u017etikrinti auk\u0161\u010diausius kokyb\u0117s standartus \u017eelatinini\u0173 kapsuli\u0173 bandymuose<\/p>\n\n\n\n

Daugiau informacijos apie Mink\u0161tos gelio kapsul\u0117s<\/h2>\n\n\n\n

Yra nustatytos taisykl\u0117s, susijusios su agelatino kietumo testerino kapsuli\u0173 produkt\u0173 vartojimu. Paprastai reikalaujam\u0173 tyrim\u0173 skai\u010dius priklauso nuo kapsuli\u0173 vieneto doz\u0117s. Ta\u010diau jis teikia daug kit\u0173 privalum\u0173, kuriuos \u0161iame straipsnyje ir panagrin\u0117sime.<\/p>\n\n\n\n

Bet pirmiausia, k\u0105 reikia \u017einoti apie mink\u0161to gelio kapsules. \u0160ie produktai da\u017eniausiai naudojami vaistams, mineraliniams papildams ir vitaminams. Kapsul\u0117s arba mikrokapsuli\u0173 viduje yra supakuotos veikliosios med\u017eiagos, apsaugan\u010dios produkt\u0105 nuo \u012fvairi\u0173 veiksni\u0173.<\/p>\n\n\n\n

\u0160ios veikliosios med\u017eiagos i\u0161siskiria difuzijos, lydymosi, tirpimo arba ply\u0161imo b\u016bdu, kai \u017emogus \u012fsideda kapsul\u0119 \u012f burn\u0105. Kaip l\u0117tai ar greitai i\u0161siskirs veikliosios med\u017eiagos, priklauso nuo kapsul\u0117s sienel\u0117s tvirtumo.<\/p>\n\n\n\n

Mink\u0161tos \u017eel\u0117 kapsul\u0117s, dar vadinamos \u017eel\u0117 kapsul\u0117mis arba \u017eelatinos kapsul\u0117mis, gaminamos i\u0161 gyv\u016bn\u0173 kaul\u0173 ir odos kolageno, i\u0161 kurio gaminama \u017eelatina. Taip pat yra vegetari\u0161k\u0173 arba augalini\u0173 kapsuli\u0173, pagamint\u0173 i\u0161 celiulioz\u0117s, kuri\u0173 pagrindin\u0117 sudedamoji dalis yra HPMC arba hidroksipropilmetilceliulioz\u0117. Ta\u010diau gelio kapsules gaminti ekonomi\u0161kiau, tod\u0117l jos naudojamos pla\u010diau nei kitos r\u016b\u0161ies.<\/p>\n\n\n\n

Yra dviej\u0173 r\u016b\u0161i\u0173 \u017eelatinos kapsul\u0117s - mink\u0161to ir kieto apvalkalo.<\/p>\n\n\n\n

Mink\u0161to kiauto kapsul\u0117s<\/strong> turi aliej\u0173 arba naudoja veikli\u0105sias med\u017eiagas, suspenduotas ar i\u0161tirpintas aliejuje.<\/p>\n\n\n\n

Kietosios kapsul\u0117s su kietuoju apvalkalu<\/strong> turi miniati\u016brini\u0173 granuli\u0173 arba saus\u0173 milteli\u0173 pavidalo ingredient\u0173. Jie gaminami i\u0161 dviej\u0173 dali\u0173: Vienoje i\u0161 j\u0173 yra vaistas, o kita pus\u0117 yra didesnio skersmens ir naudojama kaip dangtelis kapsulei u\u017edaryti.<\/p>\n\n\n\n

Viskas apie \"Gelomat\" kapsul\u0119 Kietumo testeris<\/a><\/h2>\n\n\n\n

\"Gelomat\" - tai prietaisas, naudojamas kapsul\u0117s kietumui automati\u0161kai patikrinti. Jis tinka tiek mink\u0161toms, tiek \u012fprastoms kapsul\u0117ms. Juo galima atlikti valgomosios \u017eelatinos, plastilino, \u017eelatinos kapsuli\u0173 ir kit\u0173 med\u017eiag\u0173 kietumo bandym\u0105. Jis tiekiamas su standartine bandymo galvute, ta\u010diau galima prid\u0117ti kit\u0173 pried\u0173, kad prietaisas b\u016bt\u0173 patobulintas ir padid\u0117t\u0173 jo veiksmingumas.<\/p>\n\n\n\n

\"Gelomat\" siekia, kad \u017eelatinini\u0173 kapsuli\u0173 tyrimai atitikt\u0173 auk\u0161\u010diausius kokyb\u0117s standartus. Ji sukurta naudojant naujausias mokslini\u0173 tyrim\u0173 ir pl\u0117tros technologijas ir moderniausi\u0105 sistem\u0105. Prietaisas gali b\u016bti komplektuojamas su bandym\u0173 galvut\u0117mis, kuri\u0173 apkrovos galia skiriasi: 0-2N ir 0-20N. Operatorius gali pasirinkti vien\u0105 i\u0161 galvu\u010di\u0173 ir keisti jas pagal poreikius.<\/p>\n\n\n\n

Patikimo mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo testerio privalumai<\/h2>\n\n\n\n

1. Nedestrukcinis sprendimas<\/strong><\/h3>\n\n\n\n

\"Gelomat\" yra nedestruktyvus mink\u0161t\u0173j\u0173 gelio kapsuli\u0173 kietumo tikrinimo sprendimas. Be mink\u0161t\u0173j\u0173 gelio kapsuli\u0173 ir \u017eelatinos, juo taip pat galima i\u0161matuoti agar\u0173, da\u017easvyd\u017eio kamuoliuk\u0173, \u017eaidim\u0173 te\u0161los ir kt. atsparum\u0105 ir kietum\u0105. Skaitmenin\u0117s matavimo sistemos ir unikali prietaiso konstrukcija u\u017etikrina patikimiausi\u0105 ir auk\u0161\u010diausio lygio matavimo tikslum\u0105.<\/p>\n\n\n\n

Be standartin\u0117s 0-2N arba 0-20N matavimo galvut\u0117s, operatorius gali rinktis \"Centrofix\" arba \"Rotofix\". Centrofix - tai rankiniu b\u016bdu valdomas bandini\u0173 tvirtinimo \u012ftaisas. Rotofix yra pad\u0117ties nustatymo \u012ftaisas, veikiantis automati\u0161kai. Naudotojas, naudodamasis programine \u012franga, gali atlikti funkcijas, \u012fskaitant paketini\u0173 aplank\u0173 k\u016brim\u0105, histogram\u0173 per\u017ei\u016br\u0105, duomen\u0173 saugojim\u0105, rezultat\u0173 analiz\u0119 ir kt.<\/p>\n\n\n\n

Kod\u0117l tiek daug triuk\u0161mo d\u0117l mink\u0161t\u0173j\u0173 gelio kapsuli\u0173 bandym\u0173? Kapsuliavimo procesas yra kruop\u0161tus, ta\u010diau daugiausia d\u0117mesio skiriama formai. U\u017etikrinama, kad kapsul\u0117 b\u016bt\u0173 suformuota ir gal\u0117t\u0173 i\u0161laikyti u\u017epild\u0105. Kai kapsul\u0117s pereina visus b\u016btinus etapus, kad \u012fgyt\u0173 galutin\u0119 form\u0105, atliekami bandymai.<\/p>\n\n\n\n

\u010cia ap\u017evelgiami mink\u0161t\u0173j\u0173 gelio kapsuli\u0173 gamybos etapai:<\/p>\n\n\n\n

24 coli\u0173 skersmens ner\u016bdijan\u010diojo plieno b\u016bgnas l\u0117tai sukasi, kai pilama \u0161ilta skysta \u017eelatina.<\/p>\n\n\n\n

B\u016bgn\u0105 veikia 400 kubini\u0173 p\u0117d\u0173 per minut\u0119 kompresoriaus srautas, kurio oro temperat\u016bra siekia 590 F, o santykin\u0117 oro dr\u0117gm\u0117 - 20 proc.<\/p>\n\n\n\n

B\u016bgnui toliau sukantis, \u017eelatina susigeria \u012f v\u0117s\u0173 ir saus\u0105 or\u0105, kol per kit\u0105 b\u016bgno gal\u0105 perveriama elastinga ir lipni juosta.<\/p>\n\n\n\n

I\u0161 plonos juostel\u0117s suformuojamos kapsul\u0117s. Procesas vyksta automati\u0161kai.<\/p>\n\n\n\n

Kapsul\u0117s pripildytos gamintojo produkt\u0173, toki\u0173 kaip vitaminai, vaistai, papildai ir kt.<\/p>\n\n\n\n

U\u017epildytos kapsul\u0117s u\u017edaromos ir supilamos \u012f d\u0117kl\u0105.<\/p>\n\n\n\n

Pripildytos kapsul\u0117s vis dar dr\u0117gnos ir mink\u0161tos, tod\u0117l jos perkeliamos \u012f kameras arba d\u017eiovinimo b\u016bgnus.<\/p>\n\n\n\n

D\u017eiovinimo trukm\u0117 priklauso nuo daugelio veiksni\u0173, \u012fskaitant laik\u0105, reikaling\u0105 dr\u0117gmei pa\u0161alinti, kapsuli\u0173 skai\u010di\u0173 ir dyd\u012f.<\/p>\n\n\n\n

Taip kruop\u0161\u010diai formuojamos mink\u0161tos gelio kapsul\u0117s. Labai svarbi oro temperat\u016bra, kuri veikia b\u016bgn\u0105 pilstymo metu, nes d\u0117l jos geliai gali tapti per daug trap\u016bs arba per greitai sustingti. D\u0117l abiej\u0173 \u0161i\u0173 prie\u017eas\u010di\u0173 gamyba gali b\u016bti sustabdyta ir procesas kartojamas i\u0161 naujo.<\/p>\n\n\n\n

Kai oro greitis yra per didelis, gelio kapsuli\u0173 storis arba plonumas nebus vienodas. Kita vertus, kai jis per ma\u017eas, o dr\u0117gm\u0117 ir oro temperat\u016bra per auk\u0161ta, \u017eelatinai bus sunku sukiet\u0117ti.<\/p>\n\n\n\n

D\u017eiovinimo metu reikia nuolat kontroliuoti aplinkos temperat\u016br\u0105. Idealus dr\u0117gm\u0117s lygis yra 20 gr\u016bd\u0173 vienam kilogramui oro, o rasos ta\u0161kas - 25\u00b0 F.<\/p>\n\n\n\n

Kai kapsul\u0117s visi\u0161kai i\u0161d\u017ei\u016bsta, jos patikrinamos naudojant mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo tester\u012f, pavyzd\u017eiui, \"Gelomat\". Net ir tada kapsuli\u0173, kurios galiausiai bus parduotos rinkai, skai\u010dius priklauso nuo testo rezultat\u0173. Taip u\u017etikrinama, kad u\u017ekonservuotos atsargos yra vertingos ir nepakenks gamintojo vardui.<\/p>\n\n\n\n

Kod\u0117l svarbu, kad prietaisas b\u016bt\u0173 labai lengvai atkuriamas? Kapsul\u0117s bandomos partijomis, tod\u0117l kiekviena partijos kapsul\u0117 turi pasi\u017eym\u0117ti pana\u0161iomis savyb\u0117mis ir kietumu kaip ir kitos.<\/p>\n\n\n\n

2. Testeris sukurtas siekiant u\u017etikrinti ilgaam\u017ei\u0161kum\u0105 ir tikslum\u0105.<\/strong><\/h3>\n\n\n\n

\u0160is \u017eelatinos kietumo testeris sukurtas laikantis auk\u0161\u010diausio standartinio tikslumo, koks tik gali b\u016bti taikomas Vokietijoje pagamintam prietaisui. Be to, j\u012f galima labai gerai atkurti.<\/p>\n\n\n\n

Kod\u0117l svarbu, kad prietaisas b\u016bt\u0173 labai lengvai atkuriamas? Kapsul\u0117s bandomos partijomis, tod\u0117l kiekviena partijos kapsul\u0117 turi pasi\u017eym\u0117ti pana\u0161iomis savyb\u0117mis ir kietumu kaip ir kitos.<\/p>\n\n\n\n

Nenor\u0117tum\u0117te, kad vartotojas pasteb\u0117t\u0173 skirtumus ir padaryt\u0173 i\u0161vad\u0105, kad mink\u0161tesni\u0173 produkt\u0173 galiojimo laikas pasibaig\u0119s arba kad jam buvo duoti neautenti\u0161ki produktai. Auk\u0161\u010diausi\u0105 patikimumo laipsn\u012f galima pasiekti tik tada, kai kapsul\u0117s yra labai tiksliai atkartojamos.<\/p>\n\n\n\n

Moksle atkuriamumas yra paskutinis ir tre\u010diasis tikslumo bandymo etapas. Stabilumui pasiekti parenkama \u017eymen\u0173 sistema, priklausomai nuo tiriamo produkto. Tiriant \u017eelatinos kapsules, tinkamas svorio santykis yra sausas plastifikatorius.<\/p>\n\n\n\n

Sausos \u017eelatinos ir vandens santykis yra 1:1, o sausos \u017eelatinos - 0,4-0,6:1,0. Kai gautas svorio santykis yra 1,8:1, tai rei\u0161kia, kad apvalkalas yra mink\u0161tas. Kad kapsul\u0117 b\u016bt\u0173 kie\u010diausios formos, plastifikatoriaus ir \u017eelatinos svorio santykis turi b\u016bti 0,3:1,0.<\/p>\n\n\n\n

3. Tinka \u012fvairioms pramon\u0117s \u0161akoms - farmacijos pramonei<\/strong><\/h3>\n\n\n\n

Tablet\u0117s kietumo testeris pirmiausia naudojamas farmacijos pramon\u0117je. \u0160iuo laboratoriniu bandymu nustatomas tablet\u0117s strukt\u016brinis vientisumas ir l\u016b\u017eio ta\u0161kas. Nustatoma, kaip jis kinta tvarkant, pakuojant, transportuojant ir sand\u0117liuojant. Nuo formos priklauso tablet\u0117s l\u016b\u017eio ta\u0161kas.<\/p>\n\n\n\n

Tokie testeriai naudojami nuo XX a. tre\u010diojo de\u0161imtme\u010dio. Ta\u010diau tik 1953 m. j\u012f u\u017epatentavo Robertas Albrechtas ir pavadino Strong-Cobb testeriu. Tuo metu jis buvo naudojamas kaip oro siurblys.<\/p>\n\n\n\n

Senesni\u0173 modeli\u0173 testeri\u0173 problema buvo ta, kad rezultatai buvo nenuosekl\u016bs. B\u016btent tai \u012fveik\u0117 naujesni modeliai, pavyzd\u017eiui, \"Gelomat\".<\/p>\n\n\n\n

Tai \u012fmanoma, nes \u012f \u0161\u012f gerai \u017einom\u0105 prietais\u0105 \u012fdiegtos \u0161ios funkcijos:<\/p>\n\n\n\n

Visi\u0161kas automatinio matavimo proceso integravimas<\/p>\n\n\n\n

Histerez\u0117s funkcija<\/p>\n\n\n\n

Didelis bandym\u0173 efektyvumas ir auk\u0161\u010diausias tikslumas<\/p>\n\n\n\n

Pritaikyti laikymo \u012ftaisai<\/p>\n\n\n\n

Patogus ir greitas duomen\u0173 perdavimas per USB jungt\u012f<\/p>\n\n\n\n

Patogi sistema, sukurta siekiant u\u017etikrinti pakartojamum\u0105 ir auk\u0161\u010diausius tikslumo standartus<\/p>\n\n\n\n

Automatinio koregavimo funkcija<\/p>\n\n\n\n

Skaitmeniniame ekrane rodoma, kada gautos vert\u0117s yra ma\u017eesn\u0117s arba didesn\u0117s u\u017e ribin\u0119 vert\u0119<\/p>\n\n\n\n

Skaitmeninis ekranas gali atlikti \u012fvairias funkcijas, \u012fskaitant laiko ir diapazono matavim\u0105.<\/p>\n\n\n\n

4. Tinka \u012fvairioms pramon\u0117s \u0161akoms - da\u017easvyd\u017eio pramonei<\/strong><\/h3>\n\n\n\n

Kam reikalingas kietumo testeris da\u017easvyd\u017eio pramon\u0117je? Pana\u0161iai kaip ir kapsul\u0117se, taip ir da\u017easvyd\u017eio kamuoliukuose reikalingas pakartojamas ir patikimas kamuoliuk\u0173 u\u017espaudikli\u0173, statini\u0173 ir \u017eymekli\u0173 bandymo metodas. Testavimo sistema turi u\u017etikrinti tikslum\u0105, pakartojamum\u0105 ir paprastum\u0105.<\/p>\n\n\n\n

\u0160ioje pramon\u0117s \u0161akoje labai svarbu i\u0161skirti ir apibr\u0117\u017eti nepriklausomus ir priklausomus kintamuosius, kurie turi \u012ftakos da\u017easvyd\u017eio kamuoliuko trajektorijai. Kamuoliuko tikslumas labai priklauso nuo jo kokyb\u0117s. \u012e kamuoliuk\u0105 galima \u0161audyti tiesiai tik tuo atveju, jei jis n\u0117ra i\u0161sip\u016bt\u0119s, su si\u016bl\u0117mis ar \u012fdub\u0119s - veiksnius, \u012f kuriuos testuotojas atkreipia d\u0117mes\u012f ir j\u0173 atsikrato.<\/p>\n\n\n\n

Be rutuliuko kokyb\u0117s, nuo statin\u0117s kietumo priklauso ir vidin\u0117s apdailos ilgaam\u017ei\u0161kumas. Taip pat reikia, kad statin\u0117s skyl\u0117s b\u016bt\u0173 pakankamo kampo ir dyd\u017eio. U\u017epildymui daugelis gamintoj\u0173 naudoja suspaust\u0105 or\u0105, nes mano, kad jis patikimesnis ir u\u017etikrina didesn\u012f tikslum\u0105 nei CO2.<\/p>\n\n\n\n

5. Tinka \u012fvairioms pramon\u0117s \u0161akoms - kosmetikos pramonei<\/strong><\/h3>\n\n\n\n

Kosmetikos pramon\u0117je yra daug produkt\u0173, kuriems b\u016bt\u0173 naudinga atlikti kietumo bandymus. Pavyzd\u017eiui, kosmetikos pagrindo testas atliekamas siekiant u\u017etikrinti, kad jis b\u016bt\u0173 pakankamai kietas spaud\u017eiant ir atitikt\u0173 nustatytus mokslini\u0173 tyrim\u0173 ir pl\u0117tros bei kokyb\u0117s kontrol\u0117s standartus. Paprastai tai atliekama naudojant tester\u012f, kuriame naudojama programin\u0117 \u012franga, kabelis, bandym\u0173 stendas ir j\u0117gos matuoklis. Testeris turi mechanines savybes, \u012fskaitant pl\u0117\u0161imo j\u0117g\u0105, suspaudim\u0105 ir \u012ftempim\u0105.<\/p>\n\n\n\n

Kietumo testeris taip pat gali b\u016bti naudojamas kosmetikos gamini\u0173, \u012fskaitant l\u016bp\u0173 da\u017eus, antaki\u0173 ar l\u016bp\u0173 pie\u0161tukus, va\u0161ko ir kremo gaminius, kokybei u\u017etikrinti. Pramon\u0117 labiau nei kietumu remiasi gamini\u0173 tekst\u016bros testo rezultatais. Jie turi \u012fsitikinti, kad kosmetika gerai jau\u010diasi ant odos, prie\u0161 i\u0161leisdami j\u0105 \u012f rink\u0105.<\/p>\n\n\n\n

6. I\u0161bandyti med\u017eiagas tempimo ir gniu\u017edymo at\u017evilgiu<\/strong><\/h3>\n\n\n\n

Atliekant mink\u0161t\u0173j\u0173 geli\u0173 bandymus, nustatomas kiekybinis kapsul\u0117s sieneli\u0173 stiprumas, kad b\u016bt\u0173 galima nustatyti jos ply\u0161imo ta\u0161k\u0105. Taip pat nustatomas sandariklio arba \u017eelatinos pl\u0117vel\u0117s silpnumas. Bandymai atliekami siekiant imituoti veiksnius, d\u0117l kuri\u0173 kapsul\u0117 gali ply\u0161ti dar nepasiekusi vartotojo.<\/p>\n\n\n\n

\"Gelomat\" suspaud\u017eia kapsules, kad surinkt\u0173 duomenis apie tai, ar jos i\u0161laik\u0117 kokyb\u0117s kontrol\u0119. Prietaisu tikrinamas kapsuli\u0173 sieneli\u0173 stiprumas, ar j\u0173 pakanka kapsul\u0117s formai i\u0161laikyti net ir veikiant i\u0161orin\u0117ms j\u0117goms.<\/p>\n\n\n\n

\u012erenginio paskirtis - u\u017etikrinti, kad \u012f vartotoj\u0173 rankas nepatekt\u0173 nutek\u0117jusi\u0173 kapsuli\u0173. D\u0117l to vartotojai labiau pasitiki gamintojais ir da\u017eniau perka dar kart\u0105.<\/p>\n\n\n\n

Kietumo bandymas yra tik vienas i\u0161 daugelio bandym\u0173, kurie atliekami siekiant u\u017etikrinti produkt\u0173, pvz., kapsuli\u0173, kokyb\u0119. Tas pats pasakytina ir apie da\u017easvyd\u017eio kamuoliukus bei kosmetikos gaminius. Prie\u0161 pakuojant ir parduodant visus \u0161iuos gaminius, skirtus vartotojams pirkti ar vartoti, atliekami \u012fvair\u016bs bandymai.<\/p>\n\n\n\n

Mink\u0161t\u0173j\u0173 gelio kapsuli\u0173 atveju kiekviena partija yra tikrinama, ar atitinka standartus, pagal kuriuos jos reklamuojamos ir priimtinos vartoti.<\/p>\n\n\n\n

7. Naudoja naujausias technologijas<\/strong><\/h3>\n\n\n\n

Skirtingai nuo senesni\u0173 modeli\u0173, neseniai sukurti kietumo matuokliai, pavyzd\u017eiui, Vokietijoje gaminamas \"Gelomat\", pasi\u017eymi integruota verte, efektyvumu ir naujausiomis patentuotomis technologijomis. \"Gelomat\" galima naudoti kaip m\u0117sos kietumo tester\u012f, grietin\u0117l\u0117s kietumo tester\u012f, sviesto kietumo tester\u012f ir kt. Tai rodo, kaip rimtai gamintojai siekia u\u017etikrinti, kad j\u0173 klientai gaut\u0173 geriausius produktus.<\/p>\n\n\n\n

\"Gelomat\" naudoja tikslias skaitmenines matavimo sistemas ir unikali\u0105 konstrukcij\u0105, kad procesas b\u016bt\u0173 paprastesnis ir nesuma\u017e\u0117t\u0173 tyrim\u0173 rezultatai. \u017delatinos kapsuli\u0173 kietumas matuojamas automati\u0161kai, naudojant sistem\u0105, kuria galima pasitik\u0117ti ir kuri u\u017etikrina optimal\u0173 pakartojamum\u0105 ir tikslum\u0105.<\/p>\n\n\n\n

\"Gelomat\" sistema yra viena i\u0161 vieninteli\u0173 pasaulyje, galinti b\u016bti itin lanksti, nes galima sukurti pagal u\u017esakym\u0105 pritaikytus tvirtinimo \u012ftaisus ir antgalius, atitinkan\u010dius unikalius klient\u0173 bandym\u0173 reikalavimus. D\u0117l to \"Gelomat\" sistema yra vienintelis tokio pob\u016bd\u017eio sprendim\u0173 paketas.<\/p>\n\n\n\n

8. Lengvesnis kiekybinis table\u010di\u0173 kietumo nustatymas<\/strong><\/h3>\n\n\n\n

Kietosios tablet\u0117s yra da\u017eniausia vaist\u0173 dozavimo forma. Table\u010di\u0173 kietumas sudaro produkto kokyb\u0117s kontrol\u0117s specifikacijas ir produkto k\u016brimo kriterijus.<\/p>\n\n\n\n

Tablet\u0117s kietumo testeris turi gauti kokybi\u0161kus gaminio rezultatus, t. y. kad kiekviena tablet\u0117 b\u016bt\u0173 ne per mink\u0161ta ir ne per kieta.<\/p>\n\n\n\n

Jei tablet\u0117 yra per mink\u0161ta, pacientui j\u0105 i\u0161g\u0117rus, ji gali anksti suirti. Taip gali atsitikti d\u0117l silpno sukibimo. Be to, per mink\u0161ta tablet\u0117 gali sul\u016b\u017eti arba suskilti pakuojant, dengiant ir kituose gamybos etapuose.<\/p>\n\n\n\n

Kita vertus, kai tablet\u0117 yra labai kieta, pacientui i\u0161g\u0117rus tinkam\u0105 doz\u0119, ji gali netinkamai i\u0161tirpti. Problema gali kilti d\u0117l per didelio pagalbini\u0173 ir veikli\u0173j\u0173 med\u017eiag\u0173 sukibimo potencialo.<\/p>\n\n\n\n

I\u0161tyrus tablet\u0117s kietum\u0105, galima nustatyti, ar produktas yra tinkamas vartoti ir atitinka auk\u0161\u010diausius kokyb\u0117s standartus. Ta\u010diau ji taip pat turi pasi\u017eym\u0117ti visomis mechanin\u0117mis savyb\u0117mis, reikalingomis optimaliems rezultatams pasiekti. Gamintojas turi \u012fsitikinti, kad gaminyje panaudota tinkama sudedam\u0173j\u0173 dali\u0173 sud\u0117tis, veikli\u0173j\u0173 med\u017eiag\u0173 pob\u016bdis ir naudotos ri\u0161amosios med\u017eiagos. Jie turi kontroliuoti \u0161iuos veiksnius dar gamybos metu, kad padidint\u0173 tikimyb\u0119, jog galutin\u0117s tablet\u0117s i\u0161laikys kietumo test\u0105.<\/p>\n\n\n\n

9. U\u017etikrina grie\u017et\u0105 naujausi\u0173 pramon\u0117s standart\u0173 laikym\u0105si<\/strong><\/h3>\n\n\n\n

Gaminant \u017eelatinos kapsules reikia atlikti gatav\u0173 produkt\u0173 bandymus. Galb\u016bt jau gird\u0117jote tokius terminus kaip kapsuli\u0173 kietumo testeris orgelatino kietumo testeris.<\/p>\n\n\n\n

Kad kapsul\u0117s atitikt\u0173 norminius reikalavimus ir kompendiumo standartus, atliekami \u012fvair\u016bs bandymai. Pagal bandym\u0173 rezultatus nustatoma, ar partija atitinka numatyt\u0105 naudojimo ir prekybos paskirt\u012f.<\/p>\n\n\n\n

10. \u012egyti visuomen\u0117s pasitik\u0117jim\u0105<\/strong><\/h3>\n\n\n\n

Kod\u0117l \u0161ie tyrimai yra b\u016btini? \u0160ie produktai labai priklauso nuo vartotoj\u0173 pasitik\u0117jimo. Nutek\u0117jusios kapsul\u0117s gali tur\u0117ti neigiamos \u012ftakos \u017emoni\u0173 po\u017ei\u016briui \u012f produkt\u0105 ir visus kitus to paties gamintojo produktus.<\/p>\n\n\n\n

Tod\u0117l labai svarbu, kad \u012f rink\u0105 nepatekt\u0173 nekokybi\u0161kos kapsul\u0117s; tod\u0117l gamintojai naudoja mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo tester\u012f, kad u\u017etikrint\u0173, jog visi produktai, kuriuos jie i\u0161leis \u012f rink\u0105, nepakenks j\u0173 vardui.<\/p>\n\n\n\n

Galutin\u0117s mintys<\/h2>\n\n\n\n

Naudodami mink\u0161t\u0173j\u0173 geli\u0173 kietumo tester\u012f j\u016bs\u0173 kokyb\u0117s kontrol\u0117s \u012fstaiga gaus daug naudos, ta\u010diau turite pasikliauti i\u0161bandytais ir kokybi\u0161kais prietaisais. B\u016btent tuo gars\u0117ja \"Bareiss\" - \u012fmon\u0117, kuri nuo pat savo \u012fk\u016brimo 1954 m. r\u016bpinasi technologijomis ir naujov\u0117mis.<\/p>\n\n\n\n

Testavimas: Kiek j\u016bs\u0173 kapsul\u0117s atsparios nuot\u0117kiui?<\/h2>\n\n\n\n

Nutek\u0117jusios \u017eelatinos kapsul\u0117s ma\u017eina vartotoj\u0173 pasitik\u0117jim\u0105 produktu ir gamintoju. Kad nekokybi\u0161kos kapsul\u0117s nepatekt\u0173 \u012f rink\u0105, turite sukurti testus joms nustatyti. Vienas i\u0161 metod\u0173 - naudoti tekst\u016bros analizatoriaus prietais\u0105, kuris veikia \u017eelatinos kapsules tempimo ir gniu\u017edymo j\u0117gomis, kad patvirtint\u0173, jog j\u0173 sienel\u0117s yra pakankamai tvirtos, kad atlaikyt\u0173 i\u0161orines j\u0117gas gamybos, sand\u0117liavimo, pakavimo ir transportavimo metu. <\/p>\n\n\n\n

Formuojant kapsulin\u012f vaist\u0105, svarbu \u017einoti, ar u\u017epildas - tiek API, tiek pagalbin\u0117s med\u017eiagos - yra suderinamas su \u017eelatinos apvalkalu, kur\u012f sudaro vandenyje tirpi\u0173 baltym\u0173 mi\u0161inys. Bet kokios med\u017eiagos, kuri\u0173 sud\u0117tyje yra aldehid\u0173 (pvz., formaldehido), gali sukelti \u017eelatinos susisiekiojim\u0105, o lizino liku\u010diai gali atsirasti \u017eelatinos gijose ir tarp j\u0173. Tai sustingdo \u017eelatinos strukt\u016br\u0105 ir sul\u0117tina jos skilim\u0105. Taip pat svarbu \u017einoti, kaip u\u017epildas s\u0105veikaus su \u017eelatinos apvalkale esan\u010diu vandens kiekiu. Pavyzd\u017eiui, labai higroskopi\u0161kas u\u017epildas gali absorbuoti vanden\u012f i\u0161 apvalkalo, tod\u0117l jis gali tapti trapus ir labiau link\u0119s l\u016b\u017eti. <\/p>\n\n\n\n

Tekst\u016bros analizatoriumi nustatomas kietojo kietlydinio mechaninis atsparumas \u017eelatinos kapsul\u0117<\/a> korpusus, kad gal\u0117tum\u0117te \u012fvertinti, kaip skirtingi u\u017epildai veikia kapsul\u0117s tvirtum\u0105 ir stabilum\u0105. Tai daroma bandiniui taikant kontroliuojamas mechanines s\u0105lygas ir kiekybi\u0161kai \u012fvertinant jo elges\u012f. Tai, kaip reaguoja bandiniai, tiesiogiai susij\u0119 su j\u0173 fizin\u0117mis savyb\u0117mis ir realiai parodo j\u0173 vidin\u0119 strukt\u016br\u0105. <\/p>\n\n\n\n

Tekst\u016bros analizatorius veikia tempimo arba gniu\u017edymo re\u017eimu ir gali atlikti ciklinius bandymus, kai deformacija atliekama kelis kartus. Prietaisas matuoja apkrovos j\u0117g\u0105, paprastai gramais, ir susieja j\u0105 su kapsul\u0117s deformacija. Rezultatai pateikiami grafiniu formatu kaip j\u0117gos priklausomyb\u0117 nuo laiko arba j\u0117gos priklausomyb\u0117 nuo atstumo. Deformacijos metu gali b\u016bti veikiami \u012fvair\u016bs tekst\u016bros parametrai, kuriuos galima steb\u0117ti bandymu sukurtoje j\u0117gos ir deformacijos kreiv\u0117je. Per pastaruosius 40 met\u0173 daugelyje akademini\u0173 tyrim\u0173, kuriuose naudota tekst\u016bros analiz\u0117, \u0161ie elgsenos parametrai susieti su jutimin\u0117mis charakteristikomis. <\/p>\n\n\n\n

Kapsul\u0117s ir kilpos tempimo bandymas <\/h2>\n\n\n\n

Jei tekst\u016bros analizatoriuje \u012frengtas kapsul\u0117s kilpos tempimo \u012ftaisas, kaip parodyta pirmiau pateiktoje nuotraukoje, galima palyginti tu\u0161\u010di\u0173 kapsuli\u0173 apvalkal\u0173 mechanin\u012f stiprum\u0105. Prakti\u0161kai du ploni strypai \u012fki\u0161ami \u012f vien\u0105 kapsul\u0117s apvalkalo pus\u0119, paprastai \u012f dangtel\u012f. Tuomet apatinis strypas \u012ftvirtinamas prie prietaiso pagrindo, o vir\u0161utinis strypas pritvirtinamas prie analizatoriaus pavaros mechanizmo. Pavaros mechanizmas vir\u0161utin\u012f stryp\u0105 kelia pastoviu grei\u010diu, paprastai nuo 0,1 iki 1,0 milimetro per sekund\u0119, i\u0161tempdamas kapsul\u0117s apvalkal\u0105 nustatytu atstumu. Kai kuriais atvejais atliekant bandym\u0105 kapsul\u0117s apvalkalas ply\u0161ta. <\/p>\n\n\n\n

Suspaudimo bandymas <\/h2>\n\n\n\n

Tekst\u016bros analizatoriumi taip pat galima i\u0161matuoti mink\u0161tosios \u017eelatinos kapsul\u0117s (softgelio) gniu\u017edymo stipr\u012f dviem bandymo metodais. Pirmuoju atveju 36 milimetr\u0173 skersmens zondu kiekybi\u0161kai \u012fvertinamas sandarumas (2 pav.), o antruoju - skvarbos bandymu - 2 milimetr\u0173 skersmens cilindriniu zondu nustatomas mink\u0161tosios \u017eelatinos ply\u0161imo ta\u0161kas. \u0160iais dviem bandymais ne tik nustatomi mink\u0161tiklio tvirtumo tr\u016bkumai, bet ir imituojamos aplinkyb\u0117s, kuriomis mink\u0161tasis gelis gali ply\u0161ti pakuojant ar transportuojant. Matuodami bet kurios kietosios ar mink\u0161tosios kapsul\u0117s sandarumo stiprum\u0105, naudokite didesn\u012f u\u017e kapsul\u0119 suspaudimo zond\u0105 ir orientuokite sandarikl\u012f statmenai zondui ir veikian\u010diai j\u0117gai. \u017dr. toliau pateikt\u0105 nuotrauk\u0105. 2 lentel\u0117je pateikiami mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo bandym\u0173 rezultatai.<\/p>\n\n\n\n

Gelio stiprumo bandymas <\/h2>\n\n\n\n

\u017delatina naudojama daugelyje pramon\u0117s \u0161ak\u0173 ir \u012fvairiose srityse, ir beveik visais atvejais tiek \u017eelatinos gamintojas, tiek galutinis vartotojas matuoja \u017eelatinos stiprum\u0105, kuris rodo jos veiksmingum\u0105. Gelio stiprumas labai priklauso nuo \u017eyd\u0117jimo stiprumo. Kitame puslapyje esan\u010dioje nuotraukoje pavaizduotas stiklainis su \u017eelatinos bandiniu, paruo\u0161tas bandymui. <\/p>\n\n\n\n

Naudodami tekst\u016bros analizatori\u0173 su standartiniu \u017eyd\u0117jimo zondu, \u017eyd\u0117jimo buteliukais ir \u017eelatinos vonia, galite atlikti paprastus bandymus ir greitai bei tiksliai nustatyti gelio stiprum\u0105, kuris matuojamas kaip j\u0117ga, reikalinga geliui deformuoti tam tikru atstumu.<\/p>\n\n\n\n

Tekst\u016bros analizatoriumi galima nustatyti \u017eelatinos gelio stiprum\u0105 pagal brit\u0173 standartin\u012f metod\u0105 \u201c\u017delatinos m\u0117gini\u0173 \u0117mimas ir bandymas\u201d (BS757:1975) arba pagal Amerikos \u017eelatinos gamintoj\u0173 instituto (GMIA) ar Europos \u017eelatinos gamintoj\u0173, kurie 1998 m. pri\u0117m\u0117 GMIA standart\u0105, standartus. Tod\u0117l visuose dabartiniuose metoduose nurodoma naudoti plok\u0161\u010di\u0105 12,7 mm skersmens cilindrin\u012f zond\u0105 su a\u0161tria briauna. (Europos metodas nurodo, kad vietoj a\u0161traus kra\u0161to naudojamas zondas su ma\u017eu spinduliu). <\/p>\n\n\n\n

\u0160\u012f metod\u0105 taip pat galima naudoti su kitomis kapsul\u0117s apvalkalo med\u017eiagomis, pavyzd\u017eiui, HPMC. Kai bandomi didelio mechaninio stiprumo bandiniai, apsvarstykite galimyb\u0119 naudoti didesn\u0117s talpos apkrovos element\u0105. Taip pat, jei bandiniai turi labai elasting\u0105 komponent\u0105, gali tekti pailginti bandymo atstum\u0105. <\/p>\n\n\n\n

I\u0161vada <\/h2>\n\n\n\n

Nustatant pagrindines savybes, kurios turi \u012ftakos galutiniam produktui, tekst\u016bros analiz\u0117 yra neatsiejama mokslini\u0173 tyrim\u0173 ir pl\u0117tros, proces\u0173 optimizavimo ir gamybos dalis. Ji padeda priimti sprendimus pradiniuose k\u016brimo etapuose ir u\u017etikrina proceso kontrol\u0119 gamybos linijoje. Nustatydami auk\u0161tas ir \u017eemas priimtinumo ribas, tekst\u016bros analiz\u0117 leid\u017eia optimizuoti gamyb\u0105 ir suma\u017einti atliek\u0173 kiek\u012f. <\/p>\n\n\n\n

Challenges of Dissolution Methods Development for Soft Gelatin Capsules<\/h2>\n\n\n\n

Noyes and Whitney first documented the study of the dissolution process in 1897 as a field of physical chemistry, which later was mimicked in pharmacy due to its importance in drug administration [74]. The dissolution of solid dosage forms attracted attention as the realization of the importance of drug dissolution concerning bioavailability was identified in the 1950s with the understanding that only dissolved drugs can diffuse through the human body [74,75,76,77,78]. Poor drug solubility and low dissolution rates potentially lead to insufficient availability of the drug at the site of action and subsequent failure of the in vivo therapeutic performance. This is independent of the fact that the drug could be an ideal structure for the target site. Essentially, if the drug is too insoluble, it can never reach its target site, and it will be of no therapeutic relevance. Characterization of the dissolution of a drug from a given dosage form is critical for the successful development of a drug product. This section discusses the current state-of-the-art of SGCs dissolution and various practical concepts of developing dissolution methods for SGCs.<\/p>\n\n\n\n

Dissolution testing is an official test used for evaluating the rate of drug release from a dosage form into the dissolution medium or solvent under standardized conditions of liquid\/solid interface, temperature, paddle speed, or solvent composition. Dissolution testing has become important in measuring the in vitro rate and extent of API release from different dosage forms, including SGCs. Dissolution can be described as a process by which molecules of a solute (e.g., API) are dissolved in a solvent to form a solution. The in vivo effectiveness of a dosage form depends on its ability to release the drug for systemic absorption. SGCs dissolution goes through three main steps, the first one being swelling and rupture of the gelatin shell, followed by release and dispersion of the fill material, and finally, the dissolution of the active ingredient(s) in the dissolution medium ( ). These processes occur in series, and thus the slowest step determines dissolution rate of the SGCs. The slowest step in this case controls the overall rate and extent of drug absorption. However, this varies from drug to drug. For poorly soluble drugs, especially BCS II and IV, their dissolution will be a rate-limiting step in the absorption process. On the other hand, for drugs that have high solubility, their dissolution will be rapid, and rate and extent of absorption can be affected by other factors, e.g., membrane permeability, enzymes degradation in the GIT, or first pass metabolism.<\/p>\n\n\n\n

A critical requirement for drug products is that they release the APIs in vivo at a predictable rate [ 9 , 82 , 83 ]. The kinetics of drug release follows the release mechanism of the system, such as diffusion through the inert matrix, diffusion across the gel, osmotic release, ion-exchange, or pH-sensitive delivery systems. Among the various mechanisms involved in API release, diffusion is the principal release mechanism, and it takes place at varying degrees in every system. Solute release models in physical chemistry preceded the development of drug delivery systems by many years [ 77 , 78 ]. In 1961, Higuchi introduced a mathematical model of drug release for diffusion-controlled systems [ 84 ]. The author analyzed the release kinetics of an ointment, assuming that it is homogeneously dispersed and is released in the planar matrix and the medium. According to the model, the release mechanism is proportional to the square root of time [ 85 ]. This model is recommended for the initial 60% of the release curve due to its approximate nature. In late 1969, Wang published an article considering the two independent mechanisms of transport, Fick\u2019s law, and polymer relaxation on the molecules\u2019 movement in the matrix [ 86 ]. Then, Peppas, in 1985, introduced a semi-empirical equation, power law, to describe drug release from polymeric devices in a generalized way [ 87 , 88 ].<\/p>\n\n\n\n

Another concept that needs to be introduced here is the drug release phenomenon. Drug dissolution rates and drug release rates are quite different. Drug release refers to the process by which the drug in a drug product is released in the dissolution medium or at the site of absorption by diffusion or dissolution of a drug product. Depending on the physical form of the API in the drug product, the release of API may be slow or immediate. As described in the previous section, dissolution is a process by which molecules of a solute are dissolved in solvent vehicles as a function of time. On the other hand, the term \u201crelease\u201d most often refers to a much more complex phenomenon. Release encompasses capsule dissolution as one of its several steps. Upon contact with the aqueous medium, water penetrates the soft gelatin shell and at least partially dissolves the API [ 81 ]. Then, the dissolved API diffuses out through the capsule shell due to concentration gradients. Furthermore, the gelatin shell might undergo significant swelling as soon as the critical water content is reached, which will result in the rupture of the shell, followed by dispersion and eventual dissolution in the release medium. Hence, several steps are involved in the process of releasing the API from SGCs drug products, with only one of them being drug dissolution.<\/p>\n\n\n\n

The dissolution rate of a drug product in each solvent is defined as the rate of transfer of individual drug molecules from the solid particles into the solution as individual molecules, and it can be expressed as the concentration of dissolved API for a given time interval. The rate of dissolution can vary depending on the form of API, e.g., the amorphous form usually has rapid dissolution compared to crystalline forms of API [ 79 , 80 ].<\/p>\n\n\n\n

Another important thermodynamic property in a discussion of dissolution processes is solubility, which may be expressed in several ways, including but not limited to molarity, molality, mole fraction, mole ratio, and parts per million. As an illustration, for the case of a drug molecule, consider an excess amount of solid that is exposed to the solvent phase at a defined temperature and pressure. In the equilibrium state, the number of drug molecules going into the solution equals the number of drug molecules which re-precipitate. Under these conditions, the solution is saturated with drug molecules and the concentration of dissolved drug under these conditions is defined as the \u201cequilibrium drug solubility\u201d (specific to the given temperature and pressure) [ 89 ]. It is important to assure that the solid phase present at the beginning of the experiment remains unaltered after reaching thermodynamic equilibrium during any solubility experiment. It is worth mentioning that, when particle size or the presence of additives, or the pH modifies the intrinsic solubility, this is usually reported as \u201capparent solubility\u201d to distinguish it from the equilibrium value. In order to avoid the inconsistency in solubility data reporting, the size of filters used in the separation of dissolved drug particles must be stated.<\/p>\n\n\n\n

However, the USP General Chapter , Disintegration and dissolution of dietary supplements, accepts a rupture test as a performance test of SGCs if the capsule content is semi-solid or liquid [ 92 ]. The rupture test is performed using apparatus 2, as described under General Chapter Dissolution , at a rotation speed of 50 rpm in 500 mL of immersion medium for a duration of 15 min. As per USP , the requirements are met if all of the SGCs tested rupture in not more than 15 min\u201d. If 1 or 2 of the SGCs rupture in more than 15 min but not more than 30 min, the test is repeated on 12 additional SGCs: not more than 2 of the total of 18 capsules tested rupture in more than 15 but not more than 30 min. For SGCs that do not conform to the above rupture test acceptance criteria, the test is repeated with the addition of papain to the medium in the amount that results in an activity of not more than 550,000 units\/L of medium or with the addition of bromelain in the amount that results in an activity of not more than 30 gelatin-digesting units\/L of medium [ 92 ]. Almukainzi et al. [ 93 ] compared the rupture and disintegration tests of SGCs of amantadine, ginseng, flaxseed oil, pseudoephedrine hydrochloride, and soybean oil. Their data showed that neither rupture test nor disintegration test was advantageous over the other. However, rupture test reached the endpoint quicker compared to the disintegration test. In another study, Bachour et al. [ 94 ] evaluated the suitability of the rupture test for stability studies of SGCs containing oil-based oral multivitamins. Their study showed that the rupture test was sensitive to stability conditions, and that the commercial drug products passed the rupture test. However, all long-term stability samples failed the rupture test using tier 2 conditions. This indicates that the rupture test may be suitable for assessing the performance of some drug products, but this will depend on the properties of fill components.<\/p>\n\n\n\n

The disintegration test is considered as one of the performance tests for the immediate release dosage forms [ 90 ]. As per the USP , disintegration is defined as \u201cthe state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core\u201d [ 91 ]. The requirements of disintegration are met if all test units have completely disintegrated or if not fewer than 16 of a total of 18 units tested are disintegrated within a predetermined time period. This does not imply complete solution of the API or the drug product.<\/p>\n\n\n\n

6.5. Practical Concepts of Developing a Dissolution Method<\/h3>\n\n\n\n

Dissolution testing is used throughout drug product development as an indicator of drug product performance. During formulation development, dissolution testing is used to demonstrate the release and uniformity of a dosage form in a simulated environment. Once the performance is established for the product, this information is used periodically during stability to determine if the characteristics of the product are changing in such a way that the product continues to or stops performing as required. Often, the performance of a drug product in dissolution shows physical behavior; however, it does not necessarily indicate performance in vivo. Therefore, correlation between dissolution and pharmacokinetic data can be used to demonstrate if dissolution testing has the ability to predict drug performance. This is referred to as establishing in vitro\u2013in vivo correlation (IVIVC) [95].<\/p>\n\n\n\n

The purpose of this section is to give an overview of the practical concepts of developing dissolution test methods for SGCs. It is important to understand that the dissolution of a product requires a number of physical changes to take place. Unlike other typical solid dose forms, SGCs must first reach the point where the integrity of the gelatin is compromised and the outer shell ruptures to allow release of the fill material. Following this, the fill components must disperse within the media to allow the active ingredients to either enter solution or distribute evenly throughout the media ( ). The challenge is that the capsule shell is very sensitive to its environment and can change relative to hardness, cross-linking, and seam integrity, which can all play a role in perceived dissolution changes when in fact they are changes in rupture time. Therefore, it is essential to develop a dissolution strategy that accounts for differences in the integrity of the capsule shell as well as changes in the fill material.<\/p>\n\n\n\n

Dissolution methods development are labor-intensive processes even with careful technique and practice. It is important to invest time in developing a procedure that can be efficiently executed on a routine basis and repeated robustly. Dissolution tests are required by the Pharmacopeias to determine the release of the drug from the dosage form in an environment with a pH from 1.2 to 7.4. For example, USP [96] requires a two-step dissolution method for enteric-coated solid oral dosage forms that demonstrates coating integrity in an acidic environment, usually 0.1 N HCl, followed by exposure to a neutral pH environment, preferably with a phosphate buffer, where the first step of dissolution method provides information about the coating quality and the potential for coating failure. The United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA) provide guidelines on the development and validation of dissolution procedures [96,97]. Most of these guidelines are for solid oral dosage forms like tablets and hard gelatin capsules; however, one cannot extrapolate these methods to SGCs without proper assessment. The choice of dissolution method should be based on the dosage form and the fill characteristics of SGCs. shows the common USP dissolution apparatus used in dissolution testing.<\/p>\n\n\n\n

 <\/h3>\n\n\n\n

Developing a discriminating dissolution test for SGCs requires special considerations and knowledge of gelatin and fill material properties and factors influencing them. Several factors affect the dissolution behavior of SGCs and subsequently affect the development of dissolution procedures. These factors include physical properties of the gelatin shell, physical and chemical properties of the fill material, chemical interaction between the gelatin shell and fill components, and moisture exchange between the shell and the fill material. In particular, moisture exchange can potentially result in brittleness of the gelatin shell, and chemical interactions between the shell and fill could result in gelatin cross-linking.<\/p>\n\n\n\n

Two key considerations in the design and development of dissolution methods are the solubility of the active ingredient and solution stability of the SGCs. To establish a suitable medium, several dissolution media should be evaluated to identify the one that achieves appropriate sink conditions. Sink conditions can be defined as the volume of medium that is at least three times the saturated solubility of the API, with the lowest quantity of designated surfactant. These studies allow optimization and observing the amount of surfactant that is needed to solvate the fill material within a time that is relevant to the dissolution test. It is more reasonable that a dissolution result reflects the properties of the API under the sink conditions; however, a medium that fails to provide sink conditions may be acceptable by the USP if it is appropriately justified. Likewise, when choosing the medium, the effect of additives such as acid and salt concentration, buffer counter-ions and co-solvents, and types of enzymes and their activity must also be evaluated and justified, if used. The solubility improvement of the API depends on various factors, including the nature of the surfactant and the fill material, temperature, pH, and ionic strength. This relationship should be understood for different surfactants and compounds before executing the dissolution experiment.<\/p>\n\n\n\n

Typical media for dissolution studies include: dilute hydrochloric acid (0.1 N), buffers in the physiologic pH range of 1 to 7.5 (i.e., phosphate, acetate, or citrate), simulated gastric or intestinal fluid (with or without enzymes), water, and surfactants such as Tween, Brij 35, Triton, polysorbate 80, cetyl trimethyl ammonium bromide (CTAB), sodium lauryl sulfate (SLS), and bile salts [100]. Some SGC formulations may contain a matrix or API that is not soluble in water or acidic environment and consequently, does not meet sink conditions in aqueous solution. In these instances, surfactants with a justified concentration may be added to the dissolution medium. The choice of surfactant and its concentration in relation to solubility and physical stability of the API is critical and must be optimized, understood, and justified. The addition of surfactant should reflect changes in the formulation and interactions among fill components and may shed light on the in vivo behavior of the SGCs.<\/p>\n\n\n\n

Surfactants play a role in dissolution by replacing water molecules on the particle surface, which reduces interfacial tension between the solution and the surface [101]. Amidon et al. has proposed that the use of media containing surfactants is a suitable method for solubilizing such drugs because various surfactants are present in the GI fluid, e.g., bile salts, lecithin, cholesterol and its esters [102]. They consist of two distinct components, hydrophilic and hydrophobic, and are categorized into four groups according to the charge on the hydrophilic group: anionic (e.g., sodium lauryl sulfate (SLS)), cationic (e.g., cetyl trimethyl ammonium bromide (CTAB), zwitterionic (e.g., alkyl betaine) [101], and non-ionic (e.g., Tween and Triton) [103,104]. Dissolution media containing cationic surfactants are better able to discriminate dissolution rates of acidic fill materials, while anionic surfactants differentiate better for basic fill materials. SLS has been reported to be the most commonly used surfactant in dissolution studies [100]. Solubility and dissolution rate enhancement by the surfactants are a function of surfactant concentration and the size of a micelle, and its stability, all of which can be related to the critical micelle concentration (CMC) [105]. The CMC is defined as the minimum concentration of a surfactant\u2019s monomer at which it aggregates to micelles and is characteristic for each surfactant. A lower CMC value for a given surfactant means the micelles are more stable [106]. Furthermore, the knowledge of the molecular structure of the surfactant can provide information on the size of the micelles.<\/p>\n\n\n\n

It is important to note that the addition of surfactant to dissolution media can sometimes cause a decrease in the dissolution rates of some drug products, and in some instances can also distort drug peaks during high-performance liquid chromatography (HPLC) analysis ( ). In a previous study [63], it was found that an immediate-release SGC, containing a poorly soluble drug, loratadine, showed peaks distortion in the presence of SLS. A similar observation of a decrease in the dissolution of gelatin capsules with SLS at lower pH has also been reported by other research groups [107,108].<\/p>\n\n\n\n

The development of simulated fluids for dissolution testing requires understanding of the physiological conditions of the GIT. It is important to note that the GIT is complex and has a regional dependence drug absorption [109]. Several physiological factors that can affect the dissolution process in vivo include: surfactants in gastric juice and bile, viscosity of the GI contents, GI mobility patterns, GI secretions, pH, buffer capacity, and co-administration of fluids or food [110]. Vertzoni et al. [111] developed a fasted-state simulated gastric fluid (FaSSGF) containing sodium taurocholate, lecithin, and pepsin at pH of 6.5 in order to assess its importance for the in vivo dissolution of lipophilic compounds. The authors concluded that simulation of the gastric content was essential in order to assess the absorption profile of lipophilic weak bases. An overview of the composition of the common in vitro bio-relevant dissolution media is provided by Klein [112] and Galia et al. [113]. Likewise, simulated dissolution media must take into account the developmental changes in gastrointestinal fluid composition because these can result in variations in luminal drug solubility between children and adults. Therefore, evaluating age-specific changes in GI fluid parameters (i.e., pepsin concentration, bile acids, luminal viscosity, pH, osmolality, etc.) is very important in order to define the composition of bio-relevant dissolution media in pediatrics [114]. Furthermore, aged population with medical conditions such as hypochlorhydria and achlorhydria have elevated gastric pH [115]. Therefore, simulated dissolution media in this population may need to be adjusted to reflect this increased pH.<\/p>\n\n\n\n

The selection of dissolution apparatus is another critical step in the dissolution evaluation of SGCs, as the mixing efficiency of fill material contents with media is very much influenced by the agitation hydrodynamics, particularly to variables such as paddle rotation speed. The two commonly used methods for evaluating the dissolution properties of SGCs are the paddle and basket methods.<\/p>\n\n\n\n

A basket apparatus has the advantage of enclosing SGCs. This method may be selected if SGCs are filled with a material that has a specific gravity less than that of water, where baskets prevent the SGC and its components from floating in the medium. One common problem observed using the basket is that during the dissolution experiment, the soft gel shell may disintegrate into a soft and sticky mass that can clog the basket\u2019s mesh, generating high variability in the results. Additionally, if the fill material is hydrophobic, i.e., an oil-based fill, dispersion into fine droplets that can pass through the basket\u2019s mesh may not take place, giving rise to a delay in dissolution that is not representative of the true properties of the SGCs. To mitigate this problem, an alternative would be using a basket with larger pores, i.e., 20 or 10 mesh sizes [116]. Pillay and Fassihi used a rotating basket method to evaluate the dissolution of lipid-based SGCs of nifedipine. Their data showed that, after six hours of dissolution test, most of the viscous oily fill formulation was still entangled within the baskets and this led to the dissolution failure [55]. This was attributed to using the standard dissolution basket with pores size of 40 mesh, combined with inappropriate hydrodynamic conditions within the basket. However, when the dissolution test was repeated using a re-designed dissolution apparatus, in this case, nifedipine SGCs showed the best dissolution profiles.<\/p>\n\n\n\n

The paddle method constitutes about 70% of the dissolution methods used by FDA-approved commercial drug products [100]. This method does not use a mesh basket to contain the capsules, and so a common initial problem observed in this method is the floating of the SGCs to the surface of the dissolution medium once it breaks. In these instances, wire coils, also known as sinkers, can be used to enclose the soft gels and hold them on the bottom of the vessel [117]. This allows the fill to be better exposed to the medium (upon shell rupture) and helps to prevent the capsule from sticking to the vessel walls. The shape and size of the sinker should be selected carefully as it can impact the dissolution process, especially in cases where SGCs swell when they encounter the dissolution medium. In previous study, it was shown that the dissolution rate obtained using the paddle method was faster, highly variable at lower time points than those obtained using the basket. In contrast, the data collected using the basket dissolution apparatus showed that the method was more selective and had less variation in terms of API release profile [63]. shows examples of SGCs that are commercially available and their dissolution methods. Other research groups have evaluated the feasibility of using the USP III in evaluating the dissolution of SGCs. Monterroza and Ponce De Le\u00f3n [118] developed a discriminating dissolution method of SGCs containing an oily suspension of micronized progesterone. They compared the dissolution profiles generated using USP 1, 2, and 3. After preliminary tests, USP 1 and USP 2 methods did not reach the target of releasing more than 85% of the API in less than 90 min. However, USP 3 showed promising prospect of releasing more than 85% of the API in less than 90 min in the presence of 250 mL of 4% of SLS in pH 6.8 phosphate.<\/p>\n\n\n\n

 <\/h3>\n\n\n\n

In some cases, such as coated SGCs, a two-step or two-tier dissolution technique must be developed [120,121,122]. The purpose of this method is to assess the integrity of the coating in the acidic conditions of the stomach and measure the drug release in lower parts of the GIT, which have near-neutral pH conditions. Manually performing the two-step dissolution test is labor-intensive and requires well-trained analysts. For example, it requires pre-heating the second medium solution, adjusting the medium by adding the second part of the solution as well as adjusting and confirming pH for six vessels within 5 min. Typically, there are two approaches towards medium modification known as medium-addition or medium-exchange. For example, both approaches may start with an acidic step, such as 0.1 N hydrochloric acid, for a certain period, followed with a buffer step, such as phosphate buffer at pH 6.8. The specific time is chosen as needed for the individual drug product. While using either approach, the pH adjustment must be accomplished in a controlled and reproducible manner via pre-heated media. The operation of adding and adjusting the pH must be done within 5 min [123]. Zhao and co-workers described a two-step dissolution method using medium addition and paddle apparatus, in which the surfactant Tween 80 was included in the media to enhance the solubility of the API in the first stage [124]. The developed dissolution method was able to discriminate against the changes in composition, manufacturing process, and stability of the drug product. When developing a two-step dissolution procedure, several factors must be carefully examined to establish a suitable medium. The most critical step is to carefully evaluate different media to identify the one that achieves the sink conditions. The fill material may have a pH-dependent solubility, so an evaluation of the solubility of the compound in both the acidic and neutral media must be made. For instance, 0.1 N HCl and 50 mM pH 6.8 phosphate buffers are commonly used media.<\/p>\n\n\n\n

The medium-addition technique, which is used for a two-step dissolution for enteric-coated capsules or two-tier dissolution testing, uses paddle or basket apparatus. This approach requires the addition of a relatively small amount of medium to each vessel in a short time. Generally, the common dissolution volumes used are in the range of 500 to 1000 mL, with 900 mL being the most commonly used in the FDA-approved drug products [100]. However, the dissolution volumes should be defined by the sink conditions. To develop a robust two-step dissolution method which can be transferred to quality control, a medium addition method is preferred where a volume of, e.g., 200 mL, can be added to 700 mL initial volume to adjust pH, and then add the surfactant, or enzyme, depending on the soft gelatin capsule drug product [124]. Furthermore, an accurate volume of the medium must be added to ensure that a volumetric error does not occur. Likewise, media addition must consider the final desired pH of the final volume. This technique is less invasive for the SGCs and is easier to conduct in a short time when running multiple batches. This approach is also less labor-intensive and allows for higher sampling throughput during the experiment run. For use in enteric-coated drug products, the API should be soluble up to the specification level in the medium of the first step to be able to detect a failure in the coating. For example, if the specification level for the first step is not more than 10% released, then this medium must be able to dissolve at least 10% of the active ingredient in the soft-gelatin capsule drug product. If the fill material is not soluble in the first-step medium, a surfactant may be added to solubilize at least 10% of the API in the fill material [124]. For use in two-tier dissolution, the fill material would require the surfactant to be present to meet solubility requirements, but also needs the enzyme to overcome the cross-linking.<\/p>\n\n\n\n

For the medium-exchange approach used for enteric-coated capsules, the acid medium is drained after the first step, and a full amount of pH 6.8 buffer that has been equilibrated at similar conditions is added to the same vessel for the buffer stage. The dosage form should be undisturbed during the medium change. The complete medium replacement method resembles the medium-addition approach in that the capsules are first introduced to an acidic medium. At the end of the first step, a sample for analysis is taken, and then the dosage form is removed from the acidic conditions. Removing technique of dosage form depends on the type of dissolution apparatus. The dosage forms may be manually moved from one vessel to another. Alternatively, the entire vessel containing the acid could be removed and replaced with another vessel containing the buffer, and the dosage form is transferred to the new vessel. The quality of the SGCs dosage form is ensured by meeting the USP acceptance criteria for the acid stage, i.e., less than 10% of the API is released from the drug product during the first step of the developed dissolution technique, and therefore, the coating is considered to have passed the acid-step test. If each unit release is not less than Q + 5% for the buffer stage, then the soft gel dosage form has passed the second step of dissolution [125]. Q represents the amount of an active ingredient dissolved in the dissolution medium, expressed as a percentage of the labelled content. To overcome the challenges of manual manipulations of adding the buffer solutions and adjusting the pH during the two-step dissolution testing, other research groups have developed semi-automated dissolution systems for these measurements [125]. The media exchange technique is challenging for SGCs, especially if the capsules have softened due to the liquid exposure, soaking alone will cause some softening but may not cause the rupture of the capsule. Therefore, the transfer of the capsule or media removal without disturbing the shell may be difficult due to mechanical stress.<\/p>\n\n\n\n

The European Medicines Agency (EMA) has developed its own guidance on in vitro dissolution tests for immediate-release drug products [126]. In dissolution guidance, EMA describes specifications for the quantity of active substance dissolved in a specified time, which is expressed as a percentage of API on the product label. The goal of the guidance is to set specifications to ensure batch-to-batch consistency and highlight possible problems with in vivo bioavailability. The guidance for solid immediate-release (IR) drug products from the European Pharmacopoeia (Ph. Eur. 5.17.1) has some differences compared with the FDA specifications. From a pharmaceutical perspective, the European Pharmacopoeia (Ph. Eur.) states that IR formulations should normally achieve in vitro dissolution of at least 80% of the drug substance within not more than 45 min. However, based on the USP guidance, in general, 85% or more of the drug substance should be released within 30 to 45 min.<\/p>\n\n\n\n

Dissolution methods for SGCs must also consider the aspect of age-related gelatin cross-linking influencing the dissolution performance. The USP permits the use of a two-tier assessment of hard and SGCs when evidence of cross-linking is present. Evidence of cross-linking usually occurs based on visual observations during the performance of the dissolution testing. This is based on the fact that the USP general chapters on dissolution as well as disintegration and dissolution of dietary supplements , allow the addition of various enzymes based on pH of the dissolution medium when hard or SGCs and gelatin-coated tablets do not conform to the dissolution or to resolve potential cross-linking issues specifications [127]. Cross-linking evidence can come in the form of poorly dissolving gelatin shell or pellicle formation, which appears as a sac surrounding and containing the fill material after the shell is dissolved (see Section 8). To overcome cross-linking, the two-tier dissolution test would involve the addition of proteolytic enzymes such as pepsin, papain, bromelain, or pancreatin to the dissolution media and repeating the dissolution [128]. These enzymes effectively digest the peptide bonds between the amino acids making up the gelatin strands in the shell. The use of enzymes for dissolution must be done with care, as the enzymes require significant mechanical mixing to get into solution, are minimally stable in solution, and can be impacted by other components of the media, such as surfactants. If a protein denaturing surfactant [129] is used in the media, a two-step tier 2 method must be performed. The first step involves the dissolution of the capsule shell using media containing an enzyme and no surfactant as a pre-treatment step. After the capsule shell is dissolved, media containing surfactant is added to complete the dissolution and solubilization of the fill and active pharmaceutical ingredient. It was observed that using the digestive enzyme while conducting the dissolution study and afterward using the surfactant showed a better effect in the two-tier method [130].<\/p>\n\n\n\n

Another important aspect that is worth discussing regarding dissolution of SGCs is the concept of an in vitro\u2013in vivo correlation (IVIVC). This is normally used to establish a relationship between an in vivo response (e.g., amount of drug absorbed) and an in vitro physicochemical property of a dosage form. The main objective of this concept is to make sure that the in vitro properties of two or more batches of the same drug product are performing similarly under in vivo conditions. Hence, this relationship is essentially important in guiding drug development and drug approval processes that are designed to mimic the in vivo drug release. There have been various studies on IVIVC of SGCs and some have shown good correlations. Meyer et al. [53] assessed whether the changes in the in vitro dissolution of hard and soft gelatin acetaminophen capsules, as a result of gelatin cross-linking, are predictive of changes in the bioavailability of the capsules under in vivo conditions. Their data showed that the in vitro rate of dissolution of hard and SGCs decreased due to cross-linking. On the other hand, the bioequivalence studies showed that both hard and SGCs, which failed to meet the USP dissolution specification in water, but complied when tested in SGF containing pepsin, were bioequivalent to the unstressed control capsules. Based on the plasma concentration parameters, the capsules that were cross-linked to the greatest extent were not bioequivalent with the unstressed control capsules. In another study, Nishimura et al. [131] attempted to predict the human plasma drug concentrations of SGCs containing a poorly soluble drug, arundic acid. SGCs were stored at short- and long-term conditions, i.e., 15 \u00b0C for 3 months and 25 \u00b0C (60% relative humidity (RH)) for 30 months, respectively. The authors showed that the in vitro dissolution data obtained with the dissolution medium containing surfactant (i.e., 2% SLS, pH 6.8) were more effective in predicting the drug plasma concentrations following oral administrations of the SGCs under both storage conditions. Likewise, Rossi et al. [132] developed and validated a dissolution test for ritonavir SGCs based on human in vivo pharmacokinetic data. The authors used a USP II method with 900 mL of dissolution medium containing water with 0.3%, 0.5%, 0.7%, or 1% (w\/v) of SLS at rotation speed of 25 rpm. Their data showed strong level A correlation between the percent of the drug dissolved versus percent absorbed. Significant in vitro\u2013in vivo correlation was achieved using dissolution medium containing water with 0.7% SLS. In another similar study, Donato et al. [133] reported similar results on the development and validation of a dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data. In this work, a new formulation of lopinavir was developed and its dissolution tests validated using in vivo data. All formulations were evaluated for in vitro dissolution containing 2.3% SLS at pH 6.0 and USP 1 at 25 rpm. At these conditions, the authors showed strong level A correlations for the fraction dissolved versus fraction absorbed.<\/p>\n\n\n\n

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Kas yra mink\u0161t\u0173j\u0173 kapsuli\u0173 kietumo testeris? Prie\u0161 pakuojant mink\u0161t\u0105sias \u017eelatinos kapsules reikia atlikti elastingumo bandym\u0105. Tam reikalingas ne bet koks paprastas testeris. Kapsuli\u0173 gamintojams reikia patikimo mink\u0161t\u0173j\u0173 \u017eelatinini\u0173 kapsuli\u0173 kietumo testerio, kad b\u016bt\u0173 u\u017etikrinta, jog j\u0173 produktai atitiko nustatytus pramon\u0117s standartus, prie\u0161 i\u0161leid\u017eiant produktus \u012f rink\u0105.<\/p>","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1022","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/posts\/1022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/comments?post=1022"}],"version-history":[{"count":0,"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/posts\/1022\/revisions"}],"wp:attachment":[{"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/media?parent=1022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/categories?post=1022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/test.geo-tester.com\/lt\/wp-json\/wp\/v2\/tags?post=1022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}