Open AccessEffects of formulation composition on the characteristics of mucoadhesive films prepared by hot‐melt extrusion technology
Author(s) -
Bhagurkar Ajinkya M.,
Darji Mittal,
Lakhani Prit,
Thipsay Priyanka,
Bandari Suresh,
Repka Michael A.
Publication year - 2019
Publication title -
journal of pharmacy and pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.745
H-Index - 118
eISSN - 2042-7158
pISSN - 0022-3573
DOI - 10.1111/jphp.13046
Subject(s) - extrusion , plasticizer , materials science , polyethylene glycol , chemical engineering , swelling , plastics extrusion , friability , polymer , composite material , ethyl cellulose , engineering
Abstract Objectives To investigate the effects of formulation composition on the physico‐chemical and drug release properties of mucoadhesive buccal films prepared by melt extrusion technology, using a response surface methodology. Methods Salbutamol sulphate, an antiasthmatic drug was used for this study. Klucel hydroxypropylcellulose ( HPC ) EF (film‐forming polymer), Benecel hydroxypropylmethylcellulose ( HPMC ) K‐15M (drug release retardant) and polyethylene glycol ( PEG ) 4500 (plasticiser) were the three independent factors utilised for the study. The responses were fitted to a full quadratic model and P ‐values for each of the factors were used to determine their significance on the film characteristics. Key findings Films were successfully extruded using the corotating twin‐screw extruder. The torque during extrusion was found to be significantly affected by all the three factors and no interaction between factors was observed. A significant interaction was observed between HPC and PEG 4500 for stiffness of films. For disintegration time and swelling index, a significant interaction was found between HPC and HPMC . The in vitro % drug release was directly correlated with HPMC content and not with other factors and varied from 69–89% at 4 h. Conclusions The influence of extrusion process and formulation parameters on salbutamol sulphate films was elucidated, indicating the use of melt extrusion as a feasible method for film preparation.