Research Article FORMULATION AND EVALUATION …...Research Article FORMULATION AND EVALUATION OF FAST DISINTEGRATING LOSARTAN POTASSIUM TABLETS BY FORMAL EXPERIMENTAL DESIGN Birajdar
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In the treatment of hypertension fast onset of action is the major concern. The problem of slow onset of action of drugs can be overcome by development of appropriate dosage forms. Fast disintegrating tablets in mouth are best suited and have gained popularity in the oral antihypertensive drug therapy. These are advantageous over other conventional systems in terms of patient compliance, rapid onset of action, accurate dosing, good chemical stability, convenience of self-administration and compactness. Losartan potassium is widely used as an antihypertensive drug, which is a potent drug candidate for developing in to Fast Dissolving Tablets (FDT’s). It has low bioavailability due to first pass metabolism. Hence the main objective of the study was to formulate fast dissolving tablets of Losartan potassium to achieve a better dissolution rate and further improving the bioavailability of the drug. Fast dissolving tablet of Losartan potassium were formulated by using microcrystalline cellulose with different concentration of superdisintegrants like sodium starch glycolate and Isabgol Mucilage. All the batches were prepared by direct compression. API characterization studies were conducted to check the purity of API .The tablets were evaluated for Pre compression parameters and post compression parameters. Before the formulation of the tablets IR spectroscopic studies were also performed to check the compatibility with the excipients. A 23 full factorial design was applied to investigate the combine effect of 3 formulation variables. Here the concentration of Isabgol mucilage, concentration of Sodium Starch Glycolate and concentration of Microcrystalline Cellulose were taken as independent variable X1, X2 & X3 respectively and their effect of disintegration time is studied as dependent parameter. To represent the data Design Expert software is used. Keywords: 23 full factorial design, DOE, Fast Dissolving Tablets (FDT’s), Variables. INTRODUCTION
The convenience of administration and improved patient
compliance are important in the design of oral drug delivery
system which remains the preferred route of drug delivery in
spite of various disadvantages. One such problem can be
solved in the novel drug delivery system by formulating Fast
Disintegrating Tablets (FDTs) or “Mouth Disintegrating
Tablets” (MDTs) which disintegrates or dissolves rapidly
without water within few seconds in the mouth due to the
action of superdisintegrant or maximizing pore structure in
the formulation. Fast disintegrating tablets are advantageous
particularly for pediatric, geriatric and mentally ill patients
who have difficulty in swallowing conventional tablets and
capsules. The review describes the various formulation
aspects, superdisintegrants employed and technologies
developed for MDTs, along with various excipients,
evaluation tests, marketed formulation and drugs used in this
research area.
Losartan potassium approved by the FDA in April 1995,
Losartan was launched that month as the first non-peptide
anti-hypertensive drug in the new class of Ang II receptor
antagonists. Merck began selling Losartan under the trade
names Cozaar™ and Hyzaar™. The two companies DuPont
& Merck shared the revenue. Losartan’s new mode of action
proved very effective and its selectivity very likely resulted
in its fewer side effects. It lacked the dry cough and skin rash
Birajdar S.M. et. al., August - September, 2014, 3(5), 1136-1150
the mouth. Hence, finally it was concluded that the prepared
fast dissolving tablets of Losartan potassium may prove to
be potential candidate for safe and effective fast
disintegrating tablet dosage form by Formal Experimental
Design method.
Hence, finally it was concluded that the prepared fast
dissolving tablets of Losartan potassium may prove to be
potential candidate for safe and effective fast disintegrating
tablet dosage form by Formal Experimental Design method.
Acknowledgements
The authors are thankful to Dr. Reddy’s Lab., Hyderabad &
Research-Lab Fine chem. Industries, Mumbai for providing
gift samples of API & other excipients respectively. The
authors are also thankful to Principal, Maharashtra College
of Pharmacy, Nilanga for providing necessary facility for the
work.
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How to cite your article: Birajdar S. M., Omprakas G.B., Suraj S.M., “Formulation And Evaluation of fast disintegrating losartan potassium tablets by Formal Experimental Design”, Int. J. Res. Dev.Pharm. L. Sci., 2014, 3(5), pp. 1136-1150.