Design, Development and Evaluation of Novel Mouth Dissolving Film of Tofacitinib Citrate

Abstract

Objective: The aim of the present study was to design and evaluation of mouth dissolving oral films of tofacitinib citrate allowing fast reproducible drug dissolution in oral cavity thus bypassing the first-pass metabolism to enhance the patient convenience and effective treatment for rheumatoid arthritis. Methods: Films have been prepared by way of solvent casting technique by using Hydroxypropyl methylcellulose (HPMC), sodium carboxymethylcellulose, sodium alginate, and gelatin had been used as the hydrophilic film-forming polymeric bases and glycerol as plasticizer. The prepared film evaluated for in vitro disintegration time, tensile strength, content uniformity, folding endurance, swelling index, and in vitro drug release. Results: The results of prepared film pH of all the selected formulation were ranging between 6.1 to 7.5. Thickness of the films was found in the range of 0.07 to 0.19 mm. The folding endurance was found to vary between 95.7 to 105.4-fold, Disintegration time was found 25 to 35, Drug content was found to be for F3 and F6 formulation i.e., 99.035±1.37 and 99.014±0.79. Conclusion: Thus, the current study successfully designed, developed an optimized Tofacitinib citrate formulation.

Formulation and Stability Evaluation of Anti-Obesity Nutraceuitcal Blend of White Kidney Bean Extract (Phaseolus Vulgaris L.), Propolis Ethanolic Extract and Crpic3

“…Friability test which measures the ability to withstand physical force during transportation, showed a weight loss of 0.21%±0.03 and a hardness of 4.12±0.09 kg/cm 2 . As per the guidelines set forth by the USP, oral tablets are required to have a minimum hardness of 40 N and a maximum weight loss of 1% [40][41][42]. Our findings indicated that the suggested formulation used to make the tablets dosage formula produced sufficiently hard tablets which comply with USP specifications.…”

“…The tablet powder formula, as presented in table (1), was directly compressed using the compression method to create tablets that were further assessed for weight variation, thickness, hardness, friability, and disintegration time [40].…”

“…To determine weight variation, an electronic balance was used to weighten tablets, and the mean weight was calculated [40]. The weight variation of capsules was determined following the same method.…”

Acute Oral Toxicity of Tofacitinib Citrate in Wistar Rats: Implications for Novel Mouth Dissolving Formulations

“…However, as with any new drug formulation, comprehensive safety and efficacy evaluations are needed. In contrast, we have previously published data on the Design and development of these formulations [3,4]. The pharmacokinetic behavior and potential toxicological implications are yet to be examined.…”