The aim of the present research work was to develop bilayer tablet dosage form containing combination of immediate and sustained matrix prepared from Hydrochlorothiazide (HTZ) and Losartan Potassium (LP) respectively for the treatment of hypertension and its associated complications. Immediate release HTZ was prepared using different superdisintegrants. LP sustained layer was prepared by compression technique. Both pre-compression and post-compression parameters were analyzed for all the tablets. In vitro release studies were carried out as per USP in pH (1.2) and phosphate buffer pH (6.8) using USP-XXI type II. Bilayer tablet (F6) formulated using higher concentration of HPMC K 15 exhibiting higher LP release rate (83.553± 0.22) for the period of 12 h. The In vitrorelease profile of drug from sustained matrix could be best expressed by First order as the plot showed highest linearity (R2 = 0.990) and diffusion was the dominating mechanism of drug release. The stability and FTIR studies are also indicating the absence of strong interaction between drug and polymer and compatibility among them.
Chein YW. Novel Drug Delivery Systems, 2nd ed., Marcel Dekker; New York, Madison Avenue 1992; pp. 139-196.
Guncel WC. Compression-Coated and layer tablet, 3rd ed., In: Lieberman AH, Pharmaceutical dosage forms: tablets, New York, Decker 1989; pp. 274-284.
Sampath KKP, Bhowmik D, Chiranjib CM, Tripathi KK. Innovations in sustained release drug delivery system and its market opportunities. J Chem Pharm Res 2010; 2(1): 349-60.
Micheal AE. Modified release per oral dosage forms, Pharmaceutics – The Science of Dosage form Design, 5th ed., New York, Churchill Livingston 1989; pp. 575.
Shiyani B, Gattani S, Surana S. Formulation and evaluation of bi-layer tablet of Metoclopramide hydrochloride and Ibuprofen. AAPS Pharm Sci Tech 2008; 9(3): 818-27. http://dx.doi.org/10.1208/s12249-008-9116-y
Nirmal J, Saisivam S, Peddann C, Muralidharan S, Godwinkumar S, Nagarajan M. Bilayer tablets of atorvastatin calcium and nicotinic acid: Formulation and evaluation. Chem Pharm Bull 2008; 56: 1455-8. http://dx.doi.org/10.1248/cpb.56.1455
Park CR, Munday DL. Development and evaluation of a biphasic buccal adhesive tablet for nicotine replacement therapy. Int J Pharm 2002; 237: 215-26. http://dx.doi.org/10.1016/S0378-5173(02)00041-8
Panchal HA, Tiwari AK. A Novel Approach of Bi-layer Tablet Technology- A review. Int Res J Pharm 2012; 3(5): 44-9.
Harika BI, Sirisha VNL, Kumar PK, Sruthi B, Namarata M, Rao YKK. A review on emerging trends of bilayer tablets. Int J Pharm Res Bioscience 2012; 1(5): 1-20.
Singh PK, Kumar K. Bilayer and floating Bioadhesive Tablets: Innovative approach to Gastroretension. J Drug Del Ther 2011; 1(1): 32-5.
Kumar AH, Kavitha K, Kumar SA, Kumar MR, Singh SDJ. Novel Approach of Bilayer Technology: A Review. Int J Pharm Chem Bio Sci 2013; 3(3): 887-93.
Joel MN. Low dose anti hypertensive combination therapy, its rationale and role in cardiovascular risk management. Am J Hypertens 1999; 12(8): 73-9.
Sverre EK, Paullette AL, Jorge RK, Suzanne O, Aud H, Ingrid OS. Fixed Combination of losartan and hydrochlorothiazide and reduction of risk of stroke. Vasc Health Risk Manag 2007; 3(3): 299-305.
Martin A, Bustamante P, Chun A. Micromeritics, Physical Pharmacy-Physical Chemical Principles in the Pharmaceutical Sciences, Lippincott Williams and Wilkins, Baltimore 2002.
Ansel HC, Allen LV, Popovich NG. Capsules and Tablets. In Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th ed., Lippincott Williams and Wilkins, Philadelphia 2002.
Guyot M, Fawaz F. Nifedipine loaded polymeric microspheres: preparations and physical characteristics. Int J Pharm 1998; 175: 61-74. http://dx.doi.org/10.1016/S0378-5173(98)00253-1
Makhija SN, Vavia PR. Once daily sustained release tablets of venlafaxine, a novel antidepressant. Eur J Pharm Biopharm 2002; 54: 9-15. http://dx.doi.org/10.1016/S0939-6411(02)00049-8
Higuchi F, Seta Y, Otsuka T, Nishimura K, Okada R, Koike H. Preparation and Pharmacological Evaluation of captopril sustained release dosage form using only oily semisolid matrix. Int J Pharm 1988; 41: 255-62. http://dx.doi.org/10.1016/0378-5173(88)90202-5
Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. Mechanism of solute release from hydrophilic polymers. Int J Pharm 1983; 15: 25-35. http://dx.doi.org/10.1016/0378-5173(83)90064-9
Peppas NA. Analysis of Fickian and non Fickian drug release from polymers. Pharm Acta Helv 1985; 60: 110-1.
Brabander CD, Vervaet C, Remon JP. Development and Evaluation of sustained release matrix tablet. J Controlled Release 2002; 77: 245-54.
Thummel KE, Shen DD, Isoherranaen N, Smith HE. Design and Optimization of Dosage Regimens; Pharmacokinetic Data, Goodman and Gilman’s The Pharmacological Basis of Therapeutics, McGraw-Hill Medical Publishing Division, London 2006.
Mathews BR. Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm 1999; 25: 831-56. http://dx.doi.org/10.1081/DDC-100102245
Bharadwaj V, Bansal M, Sharma PK. Formulation and Evaluation of Fast Dissolving Tablets of Amlodipine Besilate Using Different Super Disintegrants and Camphor as Sublimating Agent. American- Eurasian J Sci Res 2010; 5(4): 264-9.
Costa P, Labo JSMS. Modelling and Comparison of dissolution profiles. Eur J Pharm Sci 2001; 13: 123-33. http://dx.doi.org/10.1016/S0928-0987(01)00095-1
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright (c) 2015 Manoj Kumar Mishra, Dubey Deepti , Upamanyu Neeraj