The choice of excipients and optimization of the composition of orally disintegrating tablets based on paracetamol and N-acetyl-D-glucosamine

Abstract

Aim. The choice of the qualitative and quantitative composition of excipients to provide the required mechanical strength and disintegration time when developing a pharmaceutical composition in the form of orally disintegrating tablets (ODT) based on paracetamol and N-acetyl-D-glucosamine. Materials and methods. The study object was pharmaceutically accepted excipients used in the pharmaceutical development of solid dosage forms. To conduct the statistical analysis of experimental data, a Minitab® 19.1.1 software was used. Results and discussion. The excipients (povidone of different brands, copovidone, crospovidone of different brands, croscarmellose) used when developing ODT were considered, and it was determined that copovidone and crospovidone type A showed the most optimal quality indicators of the composition. It was found that the particle sizeof crospovidone and the route of its introduction affected the rate of disintegration in the aqueous medium. Using the method of mathematical prediction the optimal content of excipients in the composition and the experimental confirmation ofthe quality indicators of the mixture selected to create ODT were determined. Conclusions. Excipients used in the development of ODT have been considered, and the excipients exhibiting the best quality indicators of the compositions have been found. Both the influence of the particle size of crospovidone, and the route of its administration have been determined. The optimal content of excipients in the composition and their experimental confirmation have been determined due to mathematical prediction.