title: Influence of capsule shell composition on the performance indicators of hypromellose capsule in comparison to hard gelatin capsules.
abstract: The purpose of this study was to assess the in vitro performances of "vegetable" capsules in comparison to hard gelatin capsules in terms of shell weight variation, reaction to different humidity conditions, resistance to stress in the absence of moisture, powder leakage, disintegration and dissolution. Two types of capsules made of HPMC produced with (Capsule 2) or without (Capsule 3) a gelling agent and hard gelatin capsules (Capsule 1) were assessed. Shell weight variability was relatively low for all tested capsules shells. Although Capsule 1 had the highest moisture content under different humidity conditions, all capsule types were unable to protect the encapsulated hygroscopic polyvinylpyrrolidone (PVP) powder from surrounding humidity. The initial disintegration for all Capsule 1 occurred within 3 min, but for other types of capsules within 6 min (n = 18). Dissolution of acetaminophen was better when the deionized water (DIW) temperature increased from 32 to 42 °C in case of Capsule 1, but the effect of temperature was not significant for the other types of capsules. Acetaminphen dissolution from Capsule 1 was the fastest (i.e. >90% in 10 min) and independent of the media pH or contents unlike Capsule 2 which was influenced by the pH and dissolution medium contents. It is feasible to use hypromellose capsules shells with or without gelling agent for new lines of pharmaceutical products, however, there is a window for capsule shells manufacturing companies to improve the dissolution of their hypromellose capsules to match the conventional gelatin capsule shells and eventually replace them.
authors.affiliation: a Pharmaceutical Sciences Unit , College of Pharmacy, Al-Ain University of Science and Technology , Al-Ain , United Arab Emirates .
authors.forename: Moawia M
authors.initials: MM
authors.lastname: Al-Tabakha
authors.affiliation: b School of Health and Environmental Studies, Hamdan Bin Mohammed Smart University, Dubai Academic City , Dubai , United Arab Emirates , and.
authors.forename: Adi Issam
authors.initials: AI
authors.lastname: Arida
authors.affiliation: a Pharmaceutical Sciences Unit , College of Pharmacy, Al-Ain University of Science and Technology , Al-Ain , United Arab Emirates .
authors.forename: Khairi M S
authors.initials: KM
authors.lastname: Fahelelbom
authors.affiliation: c Department of Pharmacology and Therapeutics , College of Medicine and Health Sciences, United Arab Emirates University , Al Ain , United Arab Emirates.
authors.forename: Bassem
authors.initials: B
authors.lastname: Sadek
authors.affiliation: a Pharmaceutical Sciences Unit , College of Pharmacy, Al-Ain University of Science and Technology , Al-Ain , United Arab Emirates .
authors.forename: Dima Ahmed
authors.initials: DA
authors.lastname: Saeed
authors.affiliation: a Pharmaceutical Sciences Unit , College of Pharmacy, Al-Ain University of Science and Technology , Al-Ain , United Arab Emirates .
authors.forename: Rami A
authors.initials: RA
authors.lastname: Abu Jarad
authors.affiliation: a Pharmaceutical Sciences Unit , College of Pharmacy, Al-Ain University of Science and Technology , Al-Ain , United Arab Emirates .
authors.forename: Jeevani
authors.initials: J
authors.lastname: Jawadi
mesh_terms: D000082:Acetaminophen / Q000737:chemistry*; D002214:Capsules / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D065546:Drug Liberation; D005780:Gelatin / Q000737:chemistry*; D006813:Humidity; D065347:Hypromellose Derivatives / Q000737:chemistry*; D011205:Povidone / Q000737:chemistry; D012995:Solubility; D013696:Temperature; D017155:Wettability
chemical_list: D002214:Capsules; D000082:Acetaminophen; D065347:Hypromellose Derivatives; D005780:Gelatin; D011205:Povidone
keywords: Dissolution; hard gelatin capsules; hygroscopicity; hypromellose capsules; initial disintegration time; powder leakage; resistance to stress; shell weight variation