IMPROVEMENT AND ESTIMATION OF ORALLY DISINTEGRATING TABLETS CONTAINING PILOCARPINE 2-HYDROXY PROPYL β-CYCLODEXTRIN INCLUSION COMPLEX BY RESPONSE SURFACE METHODOLOGY
Abstract
Objective: The study aimed to develop and evaluate an orally disintegrating tablet that contains pilocarpine and 2-hydroxy propyl β-cyclodextrin as an inclusion complex that is prepared by lyophilization used for treatment for dry mouth. Pilocarpine is utilized to treat dry mouth disorder. The inclusion complex lowers the taste of pilocarpine through the oral mucosa by the use of 2-hydroxy propyl β-cyclodextrin.
Methods: The in vitro release from the insertion complex is also been studied. The parameters like differential scanning calorimetry (DSC), Fourier transformer infrared spectroscopy (FTIR), X-ray diffraction (XRD), and morphological study have been evaluated. The design of an experiment is carried out based on the concentration of croscarmellose sodium (CCS) and microcrystalline cellulose (MCC). Evaluation of the prepared orally disintegrating tablets have been carried out by different test methods like weight variation, thickness, drug content, disintegration, and in vitro dissolution study.
Results: Orally disintegrating tablets are studied by utilizing the immediate pressure technique. Pilocarpine indicates the anhydrous crystalline medication, displaying sharp endothermic top at 120.2 °C, bend of 2-HPβCD demonstrates an exceptionally wide endothermal wonder among 55-100 °C for DSC. In pilocarpine spectra, characteristic band of aromatic C-H stretch at 3277 cm-1, C=C stretching at 1608 cm-1, C-N stretching at 1445 cm-1 and methoxy (CH3-O-) stretch at 2921 cm-1 was observed. The investigation shows that tablet hardness of 4.3N, breaking downtime of 12 sec and mean disintegration time is 1.562 min.
Conclusion: The different diluents and super disintegrating have been applied for the quick elevation of dry mouth that helps us for patient compliance.
References
2. Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clin Ther 2008;30:2120–32.
3. Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol 2005;59:674–6.
4. Meyerhof W, Behrens M, Brockhoff A, Bufe B, Kuhn C. Human bitter taste perception. Chem Senses 2005;30 Suppl:21–3.
5. Purnamasari NAD, Saputra PA. Evaluation of orally disintegrating tablet of ibuprofen-?-cyclodextrin inclusion complex. Int J Appl Pharm 2020;12:60–4.
6. Sharma S, Lewis S. Taste masking technologies: a review. Int J Pharm Pharm Sci 2010;2:6–13.
7. Marchi N, Batra A, Tuxhorn I, Granata T, de Curtis M, Janigro D. Inflammation: cerebrovascular diseases, seizures, and epilepsy. Encycl Basic Epilepsy Res 2009;11:574–84.
8. Veiga F, Teixeira Dias JJC, Kedzierewicz F, Sousa A, Maincent P. Inclusion complexation of tolbutamide with ?-cyclodextrin and hydroxypropyl-?-cyclodextrin. Int J Pharm 1996;129:63–71.
9. Ernest TB, Elder DP, Martini LG, Roberts M, Ford JL. Developing paediatric medicines: identifying the needs and recognizing the challenges. J Pharm Pharmacol 2007;59:1043–55.
10. Sana S, Rajani A, Sumedha N, Mahesh B. Formulation and evaluation of taste masked oral suspension of dextromethorphan hydrobromide. Int J Drug Dev Res 2012;4:159–72.
11. Khan MS, Vishakante GD, Bathool A. Development and characterization of pilocarpine loaded Eudragit nanosuspensions for ocular drug delivery. J Biomed Nanotechnol 2013;9:124–31.
12. Zingone G, Rubessa F. Preformulation study of the inclusion complex warfarin-?-cyclodextrin. Int J Pharm 2005;291:3–10.
13. Coates J. Interpretation of infrared spectra, a practical approach. Encycl Anal Chem; 2006. p. 1–23.
14. Patel R, Purohit N. Physico-chemical characterization and in vitro dissolution assessment of clonazepam-cyclodextrins inclusion compounds. AAPS PharmSciTech 2009;10:1301–12.
15. Copeland KAF. Applied linear statistical models. J Quality Technol; 1997. p. 233–3.
16. Badawy SIF, Shah KR, Surapaneni MS, Szemraj MM, Hussain M. Effect of spray-dried mannitol on the performance of microcrystalline cellulose-based wet granulated tablet formulation. Pharm Dev Technol 2010;15:339–45.
17. Thoorens G, Krier F, Leclercq B, Carlin B, Evrard B. Microcrystalline cellulose, a direct compression binder in a quality by design environment-a review. Int J Pharm 2014;473:64–72.
18. C SS. Formulation and evaluation of dextromethorphan hydrobromide controlled release hollow microspheres using natural polymer. Indones J Pharm 2014;25:181.
19. Ahmed SM, Abdel Rahman AA, Saleh SI, Ahmed MO. Comparative dissolution characteristics of bropirimine-?-cyclodextrin inclusion complex and its solid dispersion with PEG 6000. Int J Pharm 1993;96:5–11.
20. Giunta AA, Wojtkiewicz SF, Eldred MS. Overview of modern design of experiments methods for computational simulations. Aerosp Sci Meet Exhib 2003.
21. Waleczek KJ, Cabral Marques HM, Hempel B, Schmidt PC. Phase solubility studies of pure (-)-?-bisabolol and camomile essential oil with ?-cyclodextrin. Eur J Pharm Biopharm 2003;55:247–51.
22. Malladi M, Jukanti R, Nair R, Wagh S, Padakanti H, Mateti A. Design and evaluation of taste masked dextromethorphan hydrobromide oral disintegrating tablets. Acta Pharm 2010;60:267–80.
23. Sunil J. Pharmaceutical Dosage Forms: Tablets. J of Pharm Sci; 1990. p. 1043.
24. Tiwari R, Srivastava B, Tiwari G, Rai A. Extended release promethazine HCl using acrylic polymers by freeze-drying and spray-drying techniques: formulation considerations. Brazilian J Pharm Sci 2009;45:829–40.
25. Tripathi A, Parmar D, Patel U, Patel G, Daslaniya D, Bhimani B. Taste masking: a novel approach for bitter and obnoxious drugs. J Pharm Sci Biosci Res 2011;1:136–42.
26. Singh B, Chakkal SK, Ahuja N. Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology. AAPS PharmSciTech 2006;7:1–10.
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