Abstract
The present work was aimed with the objective of formulating fast dissolving films of paracetamol to enhance the convenience and compliance by the elderly and pediatric patients. The films were prepared by incorporating the prepared paracetamol physical mixtures so as to achieve the aimed percent drug release (using cyclodextrins, sucrose and polaxomer 188) in different film forming agents (hydroxyl propyl methyl cellulose E5 &E15). Particular attention was given to the selection of the suitable taste masking agents. The large dose of the drug offered the greatest challenge in optimization of film formula leading to the thickness of the film and further altering the drug release from the film. The films were characterized in term of paracetamol content, mechanical properties, and disintegration time and dissolution test. The promising film F2 having the optimal formula showing the greatest dissolution and satisfactory in in-vitro disintegration time and physico-mechanical properties compared with a reference marketed product (Paracip tablets). FT-IR studies revealed that there is no interaction between the drug and the polymers used in the study. Statistical analysis revealed significant difference between the test films and the reference product, indicated that the test formulations F1, F3, F4, and F5 exhibited enhanced percentage T90 profiles, F2 and F6 showed comparable profiles with reference.
