Cieto želatīna kapsulu iepakojumu mitruma aiztures īpašības.
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Date
2022
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Rīgas Stradiņa universitāte
Rīga Stradiņš University
Rīga Stradiņš University
Abstract
Iepakojuma veida un sastāva izvēle zāļu formu iepakošanai ir ļoti svarīga, lai produkts
tiktu aizsargāts no apkārtējās vides radītām izmaiņām un nonāktu līdz pacientam ar nemainīgi
augstu kvalitāti. Cietās zāļu formas Eiropā visbiežāk tiek iepakotas blisteros, tie sastāv no
dažādiem polimēru materiāliem. Cietās želatīna kapsulas ir jutīgas pret mitrumu, tajās esošajā
pildījumā arī var notikt reakcijas paaugstināta mitruma daudzuma klātbūtnē, tāpēc tās ir svarīgi
iepakot blisteros ar atbilstošu mitruma aiztures barjeru. Darba mērķis ir veikt zinātniskās
literatūras analīzi par blisteru veidiem un īpašībām, cieto želatīna kapsulu īpašībām, un
izvēlēties tām piemērotu blisteriepakojumu, balstoties uz iepakojumu mitruma aiztures īpašību
izpētes rezultātiem. Pētnieciskais darbs tika izstrādāts A/S “Grindeks” Gatavo zāļu formu
izstrādes nodaļā.
Izstrādājot pētniecisko darbu, tika secināts, ka PVC (polivinilhorīda) blisteriepakojumi
ar dažāda biezuma PVDC (polivinilidēnhlorīda) kārtas pārklājumu neuzrāda tikpat augstas
mitruma aiztures īpašības kā alumīnija blisteriepakojumi. Paaugstināts mitruma daudzums
izraisīja kapsulu satura ārējā izskata maiņu, kvantitatīvā satura izmaiņas, kā arī tika izmainīts
kapsulu sairšanas laiks.
The type of packaging and its composition of ingredients play a very important role in packaging pharmaceutical products, so they could maintain their quality and be protected against changes affected by the external environment. In Europe solid dosage forms are packaged mostly in blisters consisting of various polymer materials. Hard gelatin capsules are moisture sensitive, also their filling can get affected by increased moisture level, so it is very important to choose an appropriate blister material with high moisture barrier properties. The aim of this study is to analyze academic literature about types of pharmaceutical blisters and their properties, hard gelatin capsule properties, and to choose an appropriate blister packaging based on their stability studies and moisture barrier. The study “Moisture barrier properties of hard gelatin capsule packaging” was carried out in the Final Dosage Forms Development Division of JSC “Grindeks”. In this study it was concluded that PVC blister packaging with layers of PVDC of different density didn’t provide as high moisture barrier properties as aluminum blister packaging. Increased moisture level resulted in changes in appearance of the hard gelatin capsule filling, changed quantitative content and disintegration time.
The type of packaging and its composition of ingredients play a very important role in packaging pharmaceutical products, so they could maintain their quality and be protected against changes affected by the external environment. In Europe solid dosage forms are packaged mostly in blisters consisting of various polymer materials. Hard gelatin capsules are moisture sensitive, also their filling can get affected by increased moisture level, so it is very important to choose an appropriate blister material with high moisture barrier properties. The aim of this study is to analyze academic literature about types of pharmaceutical blisters and their properties, hard gelatin capsule properties, and to choose an appropriate blister packaging based on their stability studies and moisture barrier. The study “Moisture barrier properties of hard gelatin capsule packaging” was carried out in the Final Dosage Forms Development Division of JSC “Grindeks”. In this study it was concluded that PVC blister packaging with layers of PVDC of different density didn’t provide as high moisture barrier properties as aluminum blister packaging. Increased moisture level resulted in changes in appearance of the hard gelatin capsule filling, changed quantitative content and disintegration time.
Description
Farmācija
Pharmacy
Veselības aprūpe
Health Care
Pharmacy
Veselības aprūpe
Health Care
Keywords
iepakojums, blisteris, cietās zāļu formas, cietās želatīna kapsulas, mitrums, packaging, blister, solid dosage forms, hard gelatin capsules, moisture