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Research ArticleResearch

Formulation and Evaluation of Bilayer Tablets of Metoclopramide Hydrochloride and Diclofenac Sodium

Surendra G. Gattani, Sohan S. Khabiya, Jitendra R. Amrutkar and Sachin S. Kushare
PDA Journal of Pharmaceutical Science and Technology March 2012, 66 (2) 151-160; DOI: https://doi.org/10.5731/pdajpst.2012.00641
Surendra G. Gattani
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  • For correspondence: sggattani@rediffmail.com
Sohan S. Khabiya
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Jitendra R. Amrutkar
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Sachin S. Kushare
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Abstract

The main objective of the present research work was to develop a bilayer tablet of metoclopramide hydrochloride (MTH) and diclofenac sodium (DS) in separate layers to avoid incompatibility and thus to maximize the efficacy of both drugs in combination for the effective treatment of migraine headaches. MTH and DS were formulated as immediate and sustained release layers respectively. In vitro dissolution kinetic studies of an optimized (D10) batch of DS in both sustained release layer and bilayer tablet forms show good linearity of regression coefficient 0.9773 (first order equation). The results reveal that an optimized immediate release layer (M5) of MTH and a sustained release layer (D10) of DS might be suitable for the treatment of migraine by sequential release of the two drugs in a bilayer tablet.

LAY ABSTRACT: Migraine is a type of recurring headache of moderate to severe intensity associated with gastrointestinal, neurological, and autonomic symptoms. In migraine, a combination of pretreatment with antiemetics is required for symptomatic treatment, when nausea and vomiting are severe. In our present research, we have selected the metoclopramide hydrochloride (MTH) active ingredient for study because it has an antiemetic effect and is a prokinetic agent. MTH is more effective to counteract gastric stasis associated with migraine, and it enhances the rate of absorption of non-steroidal anti-inflammatory drugs (NSAIDs). In the present investigation we combine MTH and a second active ingredient, diclofenac sodium, as a formulated bilayer tablet to prevent degradation of MTH.

  • Bilayer tablet
  • Diclofenac sodium
  • Metoclopramide hydrochloride
  • HPMC K100M
  • © PDA, Inc. 2012
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PDA Journal of Pharmaceutical Science and Technology: 66 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 2
March/April 2012
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Formulation and Evaluation of Bilayer Tablets of Metoclopramide Hydrochloride and Diclofenac Sodium
Surendra G. Gattani, Sohan S. Khabiya, Jitendra R. Amrutkar, Sachin S. Kushare
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 151-160; DOI: 10.5731/pdajpst.2012.00641

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Formulation and Evaluation of Bilayer Tablets of Metoclopramide Hydrochloride and Diclofenac Sodium
Surendra G. Gattani, Sohan S. Khabiya, Jitendra R. Amrutkar, Sachin S. Kushare
PDA Journal of Pharmaceutical Science and Technology Mar 2012, 66 (2) 151-160; DOI: 10.5731/pdajpst.2012.00641
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