FORMULATION AND EVALUATION OF BUCCOADHESIVE TABLETS OF BUSPIRONE HYDROCHLORIC ACID
DOI:
https://doi.org/10.22159/ajpcr.2021.v14i1.39567Keywords:
Buccal adhesive tablets, Buspirone hydrochloric acid, Anti-Anxiety, Anxiolytic agent, Gantrez MS 955, Carbopol 934, Buccoadhesive tabletAbstract
Objective: The aim of the study was to prepare and evaluate buccal-adhesive tablets of buspirone hydrochloric acid (HCl) that avoids gastric degradation and first-pass metabolism, thereby increasing the drug bioavailability and onset of action. Buspirone HCl belongs to a class anxiolytic agent and a serotonin receptor agonist belonging to the azaspirodecanedione class of compounds.
Methods: In the present work, different ratios of Gantrez MS 955 along with Carbopol 934 were studied to give bioadhesive strength. A 32 full factorial design was applied to investigate the combined effect of Gantrez MS 955 concentration (X1) and Carbopol 934 concentration (X2).
Results: Results of the multiple regression analysis revealed that the independent variables significantly affected the dependent variables (bioadhesive strength [Y1], Q2 [Y2], Q3 [Y3], Q4 [Y4]). On the basis of multiple linear regression analysis and contour plot evaluation, it was found that the combination of two polymers possessed excellent mucoadhesive properties allowing ease of application and removal of the tablets from the buccal mucosa.
Conclusion: The formulation batch A9 fulfilled all the criteria set from the desirability search. From the in vitro diffusion study, flux was calculated for the optimized batch. A study of the effect of tablet diameter and the environmental factors on the bioadhesion of the tablet was done. To study the environmental factor on bioadhesion, prehydration time and contact time were considered. Results found that increase in prehydration time decrease in bioadhesive strength and increase in contact time increased bioadhesive strength. Thus, a stable buccoadhesive formulation optimized for formulation ingredients and process parameters was prepared successfully.
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Fatma AI, Noha AN, Boraie NA, Mortada LM. Mucoadhesive buccal patches of miconazole nitrate, in-vitro/ in-vivo performance and effect of aging. Int J Pharm 2003;264:1-14.
Pankil AG, Patel MR, Patel KR, Patel NM. A review article on mucoadhesive buccal drug delivery system. Int J Pharm Res Dev 2011;3:159-73.
Gandhi SD, Priyanka RP, Rahul U, Tambawala T, Shah MA. Mucoadhesive drug delivery systems an unusual maneuver for site specific drug delivery system. Int J Pharm Sci 2011;3:851-71.
Jain NK. Controlled and Novel Drug Delivery. 1st ed. New Delhi: CBS Publishers and Distributors; 1997. p. 52-81.
Patel KV, Patel ND, Dodiya HD, Shelat PK. Buccal bioadhesive drug delivery system, an overview. Ind J Pharm Bio Arch 2011;2:600-9.
Shojaei AH. A systemic drug delivery via the buccal mucosal route. Pharm Tech 2001;25:70-81.
Tripathi KD. Essential of Medical Pharmacology. 6th ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.; 2008. p. 171-2, 435,465-8.
Availble from: https://www.drugbank.ca/drugs/DB00490. [Last accessed on Dec 2013 6].
Raymond CR, Paul JS, Owen SC. Handbook of Pharmaceutical Excipients. 5th ed . London, United Kingdom: Pharmaceutical Press; 2009.
Nazila SM, Montakarn C, Thomas PJ. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev 2005;57:1666-91.
Lee VH, Robinson JR. Sustained and Controlled Release Drug Delivery System. New York: Marcel Dekker; 2009. 71-121, 138-71.
Ahlneck C, Zografi G. The molecular Basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm 1990;62:87-95.
Chatwal G, Anand. S. Instrumental methods of chemical analysis. In: Analytical Chemistry. 5th ed., Vol. 82. Karnataka: Himalaya Publishing House; 2002. p. 29-30.
Silverstein RM, Bassler GC, Morrill TC. Spectrometric Identification of Organic Compounds. 4th ed. New York: John Wiley and Sons, Inc.; 1981. p. 95.
Bellamy LJ. In the Infrared Spectra of Complex Organic Molecules. 2nd ed. New York: John Wiley and Sons, Inc.; 1958. p. 1.
Adnan A, Lina N, omari A. Pantoprazole sodium. In: Analytical Profile of Drug Substances and Excipients. Vol. 29. Amsterdam, Netherlands: Elsevier; 2005. p. 213-57.
Mills T, Roberson JC, Simon MJ. Instrumental Data for Drug Analysis. 3rd ed., Vol. 2. Milton Park, Abingdon-on-Thames: Taylor and Fransis; 2009. p. 1362-3.
Prasad RY, Krishnaiah R, Satyanarayana S. In vitro evaluation of guar gum as a carrier for colon specific drug delivery. J Control Rel 1998;51:281-7.
Jurairat N, Kampanart H, Satit P. Development of time pH, and enzyme-controlled colonic drug delivery using spray-dried chitosan acetate and hydroxypropyl methylcellulose. Eur J Pharm Biopharm 2008;68:253-9.
European Medicines Agency. ICH Topic Q 3 C (R3) Impurities: Residual Solvents, Note For Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95), March 1998 CPMP/ICH/283/95. Amsterdam, Netherlands: European Medicines Agency; 1998.
Raval JA, Modi SV, Shah NP. Formulation and process optimization of buccoadhesive tablet of rabeprazole. Int J Pharm Chem Sci 2012;1:277-86.
Udgirkar DB, Hiremath SN, Rao KS, Pawar D. Buccoadhesive tablets containing ketoconazole inclusion complex with β- cyclodextrin. Res J Pharm Tech 2009;4:396-404.
Higuchi T. Mechanism of sustained action medication: Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci 1963;52:1145-9.
Korsmeyer R, Gurny R, Peppas N. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm 1983;15:25-35.
Peppas NA. Analysis of fickian and non-fickian drug release from polymers. Pharm Acta Helv 1985;60:110-1.
Harland RS, Gazzaniga A, Sangalli ME. Drug/polymer matrix: Swelling and dissolution. Pharm Res 1988;5:488-94.
Hixon AW, Crowell JH. Dependence of reaction velocity upon surface and agitation. Ind Eng Chem 1931;23:923-31.
ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Drug Substances and Products Q1A(R2) Current Step 4 Version; 2003. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-r2-stabilitytesting.
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