Formulation, Development and Evaluation of Uncoated Bilayer Tablet of Anti-Hypertensive Agents
The present research work was carried out to Formulate and evaluation of bilayer tablet dosage form for the treatment of Hypertension.The objective of this study to compare the specific characteristics of Metoprolol [beta selective (cardio selective) adrenoreceptor blocking agent] and Hydrochlorothiazide (Thiazide Diuretics]) in order to design stable formulation. It can be concluded that bilayer tablet were successfully formulated to achieve immediate release of Hydrochlorothiazide (HCTZ) and tailored release of Metoprolol (MPL)by using Dual Release Drug Absorption System(DUREDAS technology).Both drugs were found to be stable in Bilayer tablet formulation and were found to be stable for few months. This bilayer tablet dosage form increases the stability which may reduce loss and cost of formulation. It improves the benefits of producer, retailer, and patients. Recently, greater attention has been focused on development of bilayer tablet formulations. Over the past 30 years, the expenses and complications involved in marketing new drug entities have increased with concomitant recognition of therapeutic advantages of conventional drug delivery system. Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, efficient pharmacological effect, better patient compliance, etc. Bilayer tablet is becoming new approach for the successful drug delivery system and for better stability in combination. Bilayer tablets can be primary option to avoid chemical incompatibilities between APIs by physical separation.
Keywords: Bilayer tablet, DUREDAS Technology, Antihypertensive, Metoprolol, Hydrochlorthiazide
2. William CG, Dusel RG. Compression coated and layer tablets, Pharmaceutical Dosage Forms: Tablets. 3rd ed. New York, Basel; 1990; p.273-276.
3. Sowers JR, Epstein M, Frohlich ED. “Diabetes, Hypertension, and Cardiovascular Disease, Hypertension” American Heart Asso. 2007; 37:1053-1059.
4. Tripathi KD. Cardiovascular Drugs. In: Essentials of Medical Pharmacology. 5th ed. Delhi: Jaypee Brothers; 2003; p.503-504.
5. Satoskar RS, Bhandarkar SD, Ainapure SS. Pharmacotherapy of Hypertension. 14th ed. Bombay: Popular Prakashan; 1995; p.358-359.
6. Giles TD, Berk BC, Black HR. “Expanding the definition and classification of Hypertension” American J Clin Hypertension, 2007; 7(9):505-512.
7. DUREDASTM technology. Available at www.elandrugtechnologies.com
8. Q4B Evaluation recommendation of Pharmacopoeial test for use in ICH region general chapter bulk density and tapped density of powders.
9. Nancy JBL, Jackson R. Drugs used in the treatment of Asthma. In: Goodman Gillman A.(Eds.).The pharmacological basis of therapeutics.10thed. New york: McGraw Hill: 2001; p.647, 735-38.
10. Jahufar S. “Development of Stable Dispersible Bi-layer Tablet of Hydrochlorothiazide and Olmesartan Midoxomil” Int J Pharm Dev. Tech. 2014; 4(4):237-44.
11. United State Pharmacopoeia, 35 NF-30, 2012; (I):5975-77
12. United State Pharmacopoeia, 29 NF-24, 2007; 28: 1061- 62.
13. Q1C ICH guideline for stability testing for new dosage forms.
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