Orodispersible films in individualized pharmacotherapy: The development of a formulation for pharmacy preparations

Abstract

Orodispersible films (ODFs) are promising drug delivery systems for customized small scale pharmacy preparations. The aim of the present study was to develop a versatile casting solution suitable for the extemporaneous production of ODFs to which active pharmaceutical ingredients (APIs) can be added. Different combinations of film forming agents and other excipients and different casting heights were tested for their suitability for production of ODFs. The best suitable casting solution contained hypromellose, carbomer, glycerol, disodium EDTA and trometamol. This casting solution was used to prepare ODFs containing water-soluble APIs (enalapril maleate and prednisolone disodium phosphate) and a poorly water-soluble API (diazepam) for which ethanol 96% was used as co-solvent.The water-soluble APIs as well as ethanol influenced the viscosity of the casting solution, mechanical properties and disintegration time of the ODFs. All ODFs containing API met the requirements on uniformity of mass and uniformity of content set by the European Pharmacopoeia (2014) (Ph. Eur.) 8th edition. In conclusion, ODFs of good pharmaceutical quality can be prepared on small scale. Hereby opening the perspective of using ODFs for individualized pharmacotherapy.

Keywords: (Poorly) water-soluble API; Carbomer 974P (PubChem CID: 8314); Casting solution; Diazepam (PubChem CID: 3016); Disintegration; Enalapril maleate (PubChem CID: 5388961); Extemporaneous pharmacy preparations; Hypromellose (PubChem CID: 57503849); Mechanical properties; Orodispersible films; Prednisolon disodium phosphate (PubChem CID: 67215242).