Poly(methyl methacrylate) salt as film forming material to design orodispersible films

Publication date: 30 March 2018
Source:European Journal of Pharmaceutical Sciences, Volume 115
Author(s): Umberto M. Musazzi, Francesca Selmin, Silvia Franzé, Chiara G.M. Gennari, Paolo Rocco, Paola Minghetti, Francesco Cilurzo
This work aims to evaluate the possible use of a poly(sodium methacrylate, methyl methacrylate) (NaPMM2) plasticized by PEG400 in the design of orodispersible films (ODF). Placebo ODF prepared by solvent casting were intended to study the impact of the polymer/plasticizer ratio and residual moisture on disintegration time, stickiness and mechanical properties. The drug loading capacity was assessed using ketoprofen and paracetamol. Placebo ODF containing PEG400 in the 10–30% w/w range and 10–15% of residual moisture content were easy-to-handle, packed without failures and completely dissolved within 30 s.NaPMM2/PEG400 in 80/20 ratio allowed up to 70% of paracetamol loading, which appeared as the largest value described in literature. This ODF showed good mechanical properties and disintegration time. The same formulation loaded with 25% or 50% ketoprofen (pKa = 4.45) swelled without disintegrating, because of a partial protonation of NaPMM2, as verified by ATR-FTIR spectroscopy. However, the addition of 5% surfactants allowed the formulation of ODF containing 25% ketoprofen that disintegrated within one minute and guaranteed the complete drug dissolution within 5 min. All the presented data, discussed in the framework of information available on such copolymer, highlighted its versatility in the design of orodispersible dosage forms.

Graphical abstract

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