Design, Formulation, and Evaluation of Risperidone Mucoadhesive Buccal Patches:

Dr. Firoz Shaik; Likitha Kalimidi; Porkodi S; Chandana R; Tilak Arasan U

doi:10.37022/tjmdr.v3i2.461

Dr. Shaik Firoz Professor, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.
Kalimidi Likitha B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.
S. Porkodi B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.
R. Chandana B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.
U. Tilak Arasan B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

DOI https://doi.org/10.37022/tjmdr.v3i2.461

Abstract

Objectives: To construct and optimize Risperidone (RIS) mucoadhesive buccal films for systemic distribution as an alternate route. To make buccal patches of Risperidone utilizing natural polymers such sodium alginate (SA), Hydroxypropyl methylcellulose (HPMC), Na CMC, and Carbopol 934 (CP 934). Method: Solvent casting created Risperidone buccal patches. The optimization study used a software-based response surface methodology approach with 2³ factorial designs to evaluate 8 formulations of Risperidone mucoadhesive buccal patches to determine the significant effect of selected independent variables on the dependent variable. To assess patch appearance, thickness, weight homogeneity, folding durability, medication content, surface pH, swelling index, and FTIR. Invitro dissolution, ex-vivo permeation, residence time, and stability tests. Results: FTIR and DSC showed that Risperidone was entirely entrapped in polymer carrier bonds with no chemical interaction. Drug distribution was uniform in buccal patches at 90.14± 0.07 and 98.75± 0.80. Conclusion: Buccal patch medicine release and penetration depended on polymer type. Hydrophilic polymers boosted buccal patch drug release. F6 was the best of F1–F8. Formulation F6 had 82.03 ±0.82% in-vitro drug release and 75.21 ± 0.42% ex-vivo permeability after 7 hours. Stability tests did not modify appearance, surface pH, content homogeneity, in-vitro residence length, medication release, or ex-vivo penetration.

Keywords: Mucoadhesive buccal films, Risperidone, Hydroxypropyl methylcellulose, Sodium Carboxyl methyl cellulose, and Carbopol 934.

Author Biographies

Dr. Shaik Firoz, Professor, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

Professor and HOD

Kalimidi Likitha, B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

Department of Pharmaceutics

S. Porkodi, B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

Department of Pharmaceutics

R. Chandana, B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

Department of Pharmaceutics

U. Tilak Arasan, B. Pharm, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupati Road, Chittoor-517127, Andhra Pradesh.

Department of Pharmaceutics,

References

1. Ananta C., DasS., DhangarS., KapasiyaS and Kanango A. Developmentandcharacterizationbuccoadhesivefilmofciprofloxacinhydrochloride,InternationalJournalofPharmaTechResearch,2009,2 (2),1050-57.
2. Anonymous,http://www.rxlist.com/Tramadolhydrochloride.
3. Anonymous,Indian Pharmacopoeia, Thecontroller ofpublication, Govt.of India, Ministry of Health and Family Welfare, New Delhi. Vol I and II,2007,134,143-162,475-480,143-162,685-688.
4. Anonymous, The United States Pharmacopoeia, XXVII, NF XXII. 27thend,Vol-3, The United States pharmacopoeial convention Inc, Rockvilley, 2009,3842-3843.
5. AttamaA .A., AkpaP. A., OnugwaL .E and IgwiloG. Novelbuccoadhesivedeliverysystemofhydrochlorothiazideformulatedwithethylcellulose- HPMC inter polymer complex,Scientific Research and Essay,2008,3 (6), 343-47.
6. Aulton M.E. Eds. Pharmaceutics, The science of dosage form design, 2ndedn,ChurchillLivingstone, NewYork, 2002,270-278.
7. Bandyopadhyay A. K. Novel drug delivery systems, 1stedn, Everest publishinghouse,Pune, 2008, 143, 194-197.
8. Bhalodia R., Basu B., Garla K., Joshi B. and Mehta K. Buccoadhesive drugdelivery systems a review, International Journal of Pharm and Bio science,2010,2, 1-23.
9. BiswajitB.,GaralaKandThimmasetty J.Formulationandevaluationofpimozidebuccalmucoadhesivepatches,InternationalJournalofPharmaceuticalSciencesandNanotechnology, 2010,2(4), 739-46.
10. Chien Y. W. Novel drug delivery systems, 1stedn, Informa healthcare, NewYork,2009, 50, 139-140,186, 197-199.
11. Dharni S and Shayeda. Formulation and in-vitro evaluation of mucoadhesivebuccalpatchesofondansetronhydrochloride,InternationalJournalofPharmaceuticalSciencesandNanotechnology, 2010,3, 1-1.
12. DonaldL.W.HandbookofPharmaceuticalcontrolledreleaseTechnology,MarcelDekker,Inc, NewYork,2005, 431,465.
13. GiradkarK. P., Channawar M. A., Kajale A. D., Sridhar E., Kamble R. S.,Bakde B. V and Chandewar A. V.Design development and in-vitro evaluationof bioadhesive dosage form for buccal route, International Journal of PharmaResearchand Development,2010,2 (6), 1-20.
14. Goudanavar P. S.,Bagali R. S.,PatilS. M and ChandraShekar S. Formulationandin-vitroevaluationofmucoadhesivebuccalfilmsofGlibenclamide,ScholarsResearchLibrary,2010,2 (1), 382-87.
15. KolandM.,Sandeep V. P and Charyulu N. R.The design and characterizationofsublingual films of ondensetron hydrochloride effect of additives on in-vitro drug release and mucosal permeation, Int.J.Chem.sci, 2009, 7 (4), 2927-2938.
16. Lachman L. Lieberman H. A and Kanig J. L. The theory and practice ofindustrial pharmacy,3 rdedn, Varghese Publishing House, Mumbai, 1991, 67-71,183-184.
17. ManavalanR.andRamasamyS.PhysicalPharmaceutics,AcceleratedStabilityTesting, 1stedn,Vignesh Publisher,Chennai, 2004,288-299.
18. ManishK.,GargG.,PushpendraK.,KulkarniG.T and Arun K. Design andin-vitroevaluationofmucoadhesivebuccalfilmscontainingfamotidine,International Journal of Pharmacy and Pharmaceutical Sciences , 2010, 2 (3),86-90.
19. Mathiowitz E. Encyclopedia of Controlled Drug Delivery, 1stedn, Wiley India Pvt.Ltd,Delhi,2009,9-6.
20. Moffat A. C., Osselton M. D.andWiddop B. In Clarke’s analysis of drugs &poisons,3rdedn, Pharmaceuticalpress, 2004,Vol-2, 1692-1693.
21. Nappinnai M., ChandanbalaRand Balaijirajan R.Formulationand evaluation
22. ofnitrendipinebuccalfilms,InternationalJournalofPharmaceuticalSciences,
2008,Sep,631-35.
23. Padmaja C., Rajalakshmi., Ramesh., Rajesh., Mahitha and Kapilraj B. Designand characterization of buccal films of risperidone, InternationalJournalofBiologicalandPharmaceuticalResearch., 2012.,3(3).,347-353.
24. RaghvendraRaoN.G.,SuryakarV.B.Designanddevelopmentofmucoadhesive drug delivery system of montelukast, International Journal ofResearchin AyurvedaandPharmacy, 2011, 2 (2),491-497.
25. Rathbone M.J., Ponchel, G. and Ghazali F.A. Oral mucosal drug delivery,1stedn,Marcel Dekker,NewYork,1996, 52-54, 241-242.
26. RaymondC.Rowe,PaulJ.SheskeyandSianC.Owen.HandbookofPharmaceutical Excipients, 4thedn, pharmaceutical press, London, 2003, 89,132,194,297,259, 323.
27. Robinson J.R. and Lee V.H.L. Controlled Drug Delivery Fundamentals andApplications,2ndedn., RevisedandExpanded,MarcelDekker,Inc,NewYork,2005,3-12, 40-43,56-57.
28. SatishbabuB.K.andSrinivasanB.P.Preparationandevaluationofbuccoadhesive films of atenolol, Indian Journal of Pharmaceutical sciences,2008,70 (2), 175-179.
29. Shafiullah., KumarP. T and Shivakumar H G. Formulation and evaluation ofchlorohexidinemucoadhesive drug delivery systems,Indian Drugs,2006,Feb,43(2), 122-125.
30. Shah D., Gaud R. S., Misra A. N and Parikh R. Formulation of a water solublemucoadhesivefilmoflycopenefortreatmentofleukoplakia,InternationalJournalofPharmaceuticalSciencesReviewandResearch, 2010,2(1),6-10.
31. Skoog D. A. Holler F. and Nieman S. Principles of instrumental analysis. 5thedn,Thomson AsiaPrivate Ltd, Singapore, 1996,410-413.
32. Surya N. R., Bhabani S. N., Amit K. Nand Biswaranjan M. Formulation andEvaluationofBuccalPatchesfor Delivery ofAtenolol., AAPS PharmSciTech,2010,11(3),1038-1044.
33. Thimmasetty J., Pandy G. S and Satish B. Design and in-vivo evaluation ofcarvedilol buccal mucoadhesive patches, PakisthanJournal ofPharm, 2008,21(3), 241-48.
34. ViramP. J., LumbhaniA. N., VijayaLakshmiPand Jha S. Formulationdevelopmentandevaluationofbuccalfilmsofcarvedilol,InternationalJournalofPharmaceuticalSciences andResearch,2010, 1(8),149-56.
35. VishnuM.P.,BhupendraG.PandMadhabhaiM.P.DesignandcharacterizationofchitosancontainingmucoadhesivebuccalpatchesofPropranololhydrochloride, ActaPharm,2007, 57,61-72.
36. Vyas S. and Khar R. K. Controlled Drug Delivery Concepts and Advances InSystems for Colon Specific Drug Delivery. 1stedn., VallabhPrakashan, NewDelhi,2002,292-294.