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. 2017 Oct:119:81-90.
doi: 10.1016/j.ejpb.2017.06.004. Epub 2017 Jun 6.

Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology

Manjeet B Pimparade  1 , Anh Vo  1 , Abhijeet S Maurya  1 , Jungeun Bae  1 , Joseph T Morott  1 , Xin Feng  1 , Dong Wuk Kim  1 , Vijay I Kulkarni  1 , Roshan Tiwari  1 , K Vanaja  2 , Reena Murthy  2 , H N Shivakumar  2 , D Neupane  3 , S R Mishra  3 , S N Murthy  1 , Michael A Repka  4
Affiliations

Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology

Manjeet B Pimparade et al. Eur J Pharm Biopharm. 2017 Oct.

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.

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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Figures

Figure 1
Figure 1
Film extrusion screw design
Figure 2
Figure 2
TGA thermograms of chlorpheniramine maleate, polymer, and excipients
Figure 3
Figure 3
(a) (b). X-ray diffraction profiles of CPM, polymer, and melt-extruded film formulations
Figure 4
Figure 4
(a) (b). Dissolution release profiles of CPM and melt-extruded film formulations
Figure 5
Figure 5
Scanning electron microscopy (SEM) images of films: formulation N2 (a, b), N7 (a, b), and N9 (a, b)
Figure 6
Figure 6
Taste evaluation in rat model
Figure 7
Figure 7
Behavioral response of rats after administration of CPM and formulation solutions, a) Normal Drinking b) Paw licking c) Scratching by paw d) Biting e) Scratching by both paws f) Oral grooming
Figure 8
Figure 8
Human taste panel evaluations: pure CPM, physical mixture (N2), and melt-extruded film (N2)
See this image and copyright information in PMC

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