| Literature DB >> 28596037 |
Manjeet B Pimparade1, Anh Vo1, Abhijeet S Maurya1, Jungeun Bae1, Joseph T Morott1, Xin Feng1, Dong Wuk Kim1, Vijay I Kulkarni1, Roshan Tiwari1, K Vanaja2, Reena Murthy2, H N Shivakumar2, D Neupane3, S R Mishra3, S N Murthy1, Michael A Repka4.
Abstract
The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6-11s) and more than 95% dissolution in 5min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for evaluation of extent of taste masking and disintegration.Entities:
Keywords: Chlorpheniramine maleate; Continuous manufacturing; Hot-melt extrusion; Human panel taste evaluation; Modified starch; Orally disintegrating film; Pediatric and geriatric; Taste-masking
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Year: 2017 PMID： 28596037 PMCID： PMC5581999 DOI： 10.1016/j.ejpb.2017.06.004
Source DB: PubMed Journal: Eur J Pharm Biopharm ISSN： 0939-6411 Impact factor: 5.571