Formulation Development and Evaluation of Fast Dissolving Oral Film of Midodrine Hydrochloride
Abstract
Oral fast dissolving midodrine hydrochloride films prepared by solvent casting method, PEG 400 was the selected plasticizers, incorporating superdisintegrants such as croscarmellose sodium (CCS) and sodium starch glycolate (SSG) to achieve the goal. Drug content, weight variability, film thickness, disintegration time, endurance, percentage of moisture content, and in vitro dissolution tests were analyzed for the prepared films. In all formulations, the tensile strength value was found from 0.965±0.045 and 1.256±0.032 and the folding capacity was over 100. The assay values ranged from 97.98±0.25 to 99.89±0.36 percent for all formulations. The disintegration time was ranging between 55±9 to 120±6 sec, the minimum time for disintegration was found in formulation F5 (55±9). The prepared F5 formulation shows greater release of the drug (99.25±0.41 percent) within 15 min relative to other formulations. As the drug having low solubility, fast disintegration may leads to more drug availability for dissolution, resulting in faster absorption in systemic circulation increased systemic availability of drug leads to quick onset of action which is prerequisite for hypertension.
Keywords: Midodrine hydrochloride, Fast dissolving films, Solvent casting method, Superdisintegrants.
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References
2. Klancke J. Dissolution testing of orally disintegrating tablets. DissolutTechnol. 2003; 10:6–8.
3. Bhatt P, Patel D, Patel A, Patel A, Nagarsheth A. Oral Controlled Release Systems: Current Strategies and Challenges. In: Misra A, Shahiwala A, editors. Novel Drug Delivery Technologies: Innovative Strategies for Drug Re-positioning. Singapore: Springer Singapore; 2019. p. 73-120.
4. Borsadia S, O’Halloran D, Osborne JL. Quick dissolving films-A novel approach to drug delivery. Drug DelivTechnol. 2003; 3:63-6.
5. http:// www.access data. fda. gov/drugsatfda_docs/ nda/2015/022524orig1s000chemr.pdf.
6. Ananda K, Kavitha MP, Krishnakumar K. A review on the determination of Midodrine hydrochloride in bulk and marketed formulations by using different analytical techniques.2020; 7(14):260-266.
7. Yellanki SK, Jagtap S, Masareddy R. Dissofilm: a novel approach for delivery of phenobarbital; design and characterization. Journal of Young Pharmacists. 2011; 3(3):181–188.
8. Joshi P, Patel H, Patel V, Panchal R. Formulation development and evaluation of mouth dissolving film of domperidone. Journal of Pharmacy and Bioallied Sciences.2012; 4(5):108-109.
9. Janben EM, Schliephacke R, Breitenbach A, Breitkreutz J. Drug-printing by flexographic printing technology-a new manufacturing process for orodispersible films. International Journal of Pharmaceutics. 2013; 441(1-2):818–825.
10. Nafee NA, Boraie NA, Ismail FA, Mortada LM. Design and characterization of mucoadhesive buccal patches containing cetylpyridinium chloride. Acta Pharmaceutica. 2003; 53(3):199–212.
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