Chitosan Loaded Mucoadhesive Microspheres of Gliclazide - Journal

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Prakash Rao B et al./ Formulation and Evaluation of Mucoadhesive Buccal Drug Delivery System of Metoprolol Tartrate by Using Central Composite Design mucoadhesive tablets of Atenolol using response surface methodology. AAPS Pharm Sci Tech 2005;7:1-9.14. http://www.itl.nist.gov/div898/ handbook/ pri/section3/pri3361.htm 15. Saikat P, Marina K, Jolly R.P., Ajay B.S., Gaurav H.S., Rahul T. Buccoadhesive Tablets of losartan: Design and Characterisation. Int. J. Pharma. Bio. Archive 2010:1;150-4. 16. Marget C., Sachin, Debjit D.,Jayakar B. Formulation and eavaluation of Mucoadhessive oral tablet of Clorithromycin. T. Pharm. Res. 2009:2;30-42. 17. Emami J, Varshosaz J, Saljioughian N. Development and evaluation of controlled release buccoadhesive Verapamil hydrochloride. Daru 2008; 16: 60-9. 18. Hirlekar R S, Kadam V J. Design of buccal drug delivery system for a poorly soluble drug. Asin. J. Pharm. Clinic. Reas., 2009:2;49-53. 19. Park CR, Munday DL. Development and evaluation of a biphasic buccal adhesive tablet for Nicotine replacement therapy. Int J Pharm 2002; 237: 215-26. 156 20. http://www.pharmainfo.net/pharmacy-student-articles/carbopol-andits-applications-pharmaceutical-dosage-forms. 21. Salamone, C. J. Polymeric materials encyclopedia. New York, USA: CRC press 1996. 22. Patel, V. M., Prajapati, B. G., & Patel, M. M.Formulation, evaluation and composition of bilayer and multilayered mucoadhesive buccal device of propranolol hydrochloride. AAPS PharmSciTech., 2006:8;1- 15. 23. Liabot, J. M., Manzo, R. H., & Allemandi, D. A. Double layered mucoadhesive tablets containing nystain. AAPS. Pharm Sci Tech., 2002:3;1-5. Address for Correspondence Dr. B. Prakash Rao, M. Pharm, Ph. D, Professor and HOD, Department of Pharmaceutical Technology, Karnataka College of Pharmacy 33/2, Thirumenahally, Hegde Nagar Main Road, Bangalore-560064 E-mail: bprao_1111@rediffmail.com RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
A B S T R A C T RGUHS Journal of Pharmaceutical Sciences Development and Evaluation of Mucoadhesive Buccal Films of Nebivolol Bushetti S.S*, Mane Prashant P and Kardame S.S HKES's College of Pharmacy, M R Medical College Campus, Sedam Road, Gulbarga- 585105 INTRODUCTION The buccal mucosa, along with other mucosal tissues, has been investigated as a potential site for controlled delivery of macromolecular therapeutic agents, such as peptides, proteins and polysaccharides because of its accessibility and low enzymatic activity compared to the gastro-intestinal tract. Another interesting advantage is its tolerance (in comparison 1 with the nasal mucosa and skin) to potential sensitizers. The potential of the buccal mucosa as an alternative site for the delivery of drugs into the systemic circulation has recently received much attention. There are many reasons why the buccal mucosa might be an attractive site for the delivery of therapeutic agents into the systemic circulation. Due to the direct drainage of blood from the buccal epithelium into the internal jugular vein, the first-pass metabolism in the liver and intestine may be avoided. This first-pass effect is a major reason for the poor bioavailability of some compounds when administered orally. Additionally, the mucosa lining the oral cavity is easily accessible, which ensures that a dosage form can be applied to the required site and can be removed easily 2 in case of emergency. The oral cavity is a moist environment; the membranes that line the oral cavity are covered with mucus which is derived mainly from minor salivary glands and are constantly bathed in saliva, an aqueous substance rich in inorganic salts, proteins and bacteria. Saliva has a variety of functions and is RGUHS Journal of Pharmaceutical Sciences Received: 28/1/2011, Modified: 21/2/2011, Accepted: 3/3/2011 Original Research Article Nebivolol a third-generation cardio selective β1-blocker that is approved for the treatment of hypertension. Nebivolol undergoes extensive metabolism in the liver after its oral administration and resulting in to a very poor (approximately 10-12%) bioavailability. Oral administration of nebivolol can also cause gastrointestinal disturbance and abdominal or stomach pain etc. In order to improve the bioavailability, efficacy and to minimize the side effects associated with oral administration, mucoadhesive buccal films of nebivolol using hydroxy propyl methyl cellulose and methyl cellulose were prepared by solvent casting technique. The films of nebivolol using hydroxy propyl methyl cellulose and methyl cellulose were smooth, elegant and uniform in thickness and weight. Among the two polymers used hydroxyl propyl methyl cellulose showed an increased in-vitro residence time due to mucoadhesion nature of the hydroxyl propyl methyl cellulose. Drug content uniformity study showed uniform dispersion of the drug throughout the film in the range of 96.208±1.0705 to th 98.887±0.2558 %. In- vitro drug release study showed that more than 90% of drug was released at the end of 8 hr. The release profile of all the formulations was subjected to various kinetic equations and the results suggested that the drug was released by diffusion mechanism following super case-II transport. Keywords: Nebivolol, Buccal films, Mucoadhesion, In vitro drug release and Diffusion. 157 continuously secreted into, distributed around and removed 3 from the oral cavity . Based on the current understanding of biochemical and physiological aspects of absorption and metabolism of biotechnologically- produced drugs, they cannot be delivered effectively through the conventional oral route. Because after oral administration many drugs are subjected to presystemic clearance extensive in liver, which often leads to a lack of significant correlation between membrane permeability, absorption, and bioavailability. Difficulties associated with parenteral delivery and poor oral availability provided the impetus for exploring alternative routes for the delivery of 4 such drugs. Nebivolol is a third-generation β1selective β-blocker used in 5 the treatment of hypertension , it works by relaxing blood vessels and slowing heart rate to improve blood flow and 6 decrease blood pressure . Nebivolol on oral administration undergoes extensive metabolism in the liver resulting into very 7 poor (approximately 10- 12%) bioavailability . It can also cause gastrointestinal disturbance and abdominal or stomach pain, etc. In order to improve its bioavailability, efficacy and to minimize the side effects associated with oral administration, mucoadhesive buccal films of nebivolol using hydroxy propyl methyl cellulose and methyl cellulose were prepared by solvent casting technique in the present investigation. MATERIALS AND METHODS Nebivolol was a gift sample from Ajanta Pharma Ltd., Mumbai. HPMC (G-236007), and MC (040801) were RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
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