Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot‐melt extrusion technology. (28th November 2018)

• Record Type: Journal Article
• Authors: Bhagurkar, Ajinkya M.; Darji, Mittal; Lakhani, Prit; Thipsay, Priyanka; Bandari, Suresh; Repka, Michael A.
• Is Part Of: Journal of pharmacy and pharmacology. Volume 71:Number 3(2019)
• Page Start: 293
• Page End: 305
• Publication Date: 2018-11-28
• Subjects: design of experiments -- hot‐melt extrusion -- hydroxypropylcellulose -- hydroxypropylmethylcellulose -- mucoadhesive films; Pharmacy -- Periodicals; Pharmacology -- Periodicals; 615.1
• DOI: 10.1111/jphp.13046
• Languages: English
• ISSNs: 0022-3573

Abstract

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.