FORMULATION DEVELOPMENT AND EVALUATION OF ELEMENTARY OSMOTIC TABLET OF LISINOPRIL DIHYDRATE

Authors

  • BHUSHAN A. BHAIRAV Department of Quality Assurance Techniques; R. G. Sapkal College of Pharmacy, Anjaneri, Nashik 422213, Maharashtra
  • PRADNYA M. KHANDAGALE Department of Quality Assurance Techniques; R. G. Sapkal College of Pharmacy, Anjaneri, Nashik 422213, Maharashtra
  • R. B. SAUDAGAR Department of Quality Assurance Techniques; R. G. Sapkal College of Pharmacy, Anjaneri, Nashik 422213, Maharashtra

DOI:

https://doi.org/10.22159/ijcpr.2017v9i5.22131

Keywords:

Lisinopril Dihydrate, Controlled Release, Elementary Osmotic Tablet, Semipermeable Membrane, Cellulose Acetate

Abstract

Objective: Lisinopril Dihydrate is one of the antihypertensive drug used to control the high blood pressure. Osmotically Controlled release tablet of Lisinopril Dihydrate was performed for reducing dosing frequency and patient compliance.

Methods: Elementary osmotic tablets of Lisinopril Dihydrate were developed using Sodium chloride as a key ingredient which gives osmogent property which provides driving force inside the core tablet and which leads to release of the drug. Microcrystalline cellulose used as a release retardant material in the present work. Different formulations were prepared by varying the concentrations using 32 factorial designs. It was applied to see the effect of variables Sodium chloride (X1) and MCC (X2) on the response percentage drug release as a dependent variable. These formulations were evaluated for, Hardness, Flow property, Thickness, Friability, Drug content and In vitro drug release. Tablets were coated with a semipermeable membrane using 5% w/v cellulose acetate(CA) in acetone and PEG 400(1%) used as Plasticizer. Coated Elementary osmotic tablets were drilled for delivery orifice using a standard micro drill of diameter size 0.8 mm.

Results: Drug release rate was increased as the increase in the concentration of sodium chloride and release rate decreased on increasing the concentration of MCC. Drug release rate was directly proportional to delivery orifice size. SEM Study carried out for detection of diameter size of the delivery orifice. The FTIR studies demonstrate that there was no interaction between polymer and drug.

Conclusion: The optimized formulation was stable for 3 mo of accelerated stability study

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References

Remington: the science and practice of pharmacy. 21st edition. Vol. I. Lippincott Williams and Wilkins; 2006. p. 939, 940.

Robinson Joseph R, Lee Vincent HL. Controlled drug delivery, fundamentals and application. 2nd edition. Vol. 20. Revised and expanded, Marcel Dekker Inc; 1987. p. 7, 8.

Tripathi KD. Essentials of Medical Pharmacology. 5th Ed. Jaypee Brothers. New Delhi; 2003. p. 390-404.

Rang HP, Dale M, Ritter JM, Moore PK. Pharmacology. 5th Ed. Elsevier, Publication; 2006. p. 525-35.

Aulton ME. Aulton’s Pharmaceutics: The design and manufacture of Medicines. 3rd ed. Churchill Livingstone; 2007. p. 336-60.

Clarke’s Analysis of drugs and poisons. 4td edition. Published by the Pharmaceutical Press; 2011. p. 675.

Marcel K. Compression and consolidation of powdered solids. In: Liberman HA, Lachman L, Kaing JL, ed. The theory and practice of industrial pharmacy. 3rd ed. New York, Marcel Dekker, Inc; 1981.

Shingala K, Singh C, Dumaniya D, Patel B. Formulation development and evaluation of immediate release tablet of poorly soluble candesartan cilexetil. J Pharm Sci Biosci Res 2013;3:77-90.

Gilbert S, Banker. Modern Pharmaceutics. drugs and pharmaceutical sciences. 4th edition. Marcel Dekker; Inc. New York; 1989. p. 607.

The Indian pharmacopoeia. The government of India, Ministry of Health and Family Welfare. The controller of publications, Ghaziabad; 2010. p. 1, 3, 147, 185-198, 1219-1220.

Pavia DL, Lampman GM, Kriz GS. Spectroscopy. Edition 4. Cennage learning Pvt ltd; 2007. p. 26-107.

Andhale S, Gondkar SB, Darekar AB, Saudagar RB. Development of osmotically controlled release tablet of quetiapine fumarate. Invent Rapid Pharm Tech 2014;3:1-12.

Aulton ME. Aulton’s Pharmaceutics: The design and manufacture of Medicines, 3rd edition. Churchill Livingstone; 2007. p. 336-60.

The Indian Pharmacopoeia 2010. The government of India, Ministry of Health and Family Welfare. The controller of publications, New Delhi; 2013. p. 1, 2.

Farheen F, Elango K, Devi DR, Santhanalakshmi G. Formulation and evaluation of controlled porosity prednisolone osmotic tablets for colon targeting. Res J Pharm Tech 2011;4:1106-10.

Leon Lachman, Herbert Libermann. The theory and practice of industrial pharmacy, CBS Publisher; Indian edition; 2009. p. 372.

Grahm C, Hogan J, Micheal A. Pharmaceutical Coating Technology, Informa Healthcare special edition; 2016. p. 152.

George M, Robinson JR. Modern Pharmaceutics. Banker GS, Rhodes H, Eds. 2nd edition Marcel Dekker Inc, New York; 1990. p. 770.

Fung H. Drug stability: principles and practice, drug and pharmaceutical sciences. Marcel Dekker, New York; 1991. p. 235.

Published

21-09-2017

How to Cite

BHAIRAV, B. A., P. M. KHANDAGALE, and R. B. SAUDAGAR. “FORMULATION DEVELOPMENT AND EVALUATION OF ELEMENTARY OSMOTIC TABLET OF LISINOPRIL DIHYDRATE”. International Journal of Current Pharmaceutical Research, vol. 9, no. 5, Sept. 2017, pp. 20-27, doi:10.22159/ijcpr.2017v9i5.22131.

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