CONCEPT OF FIXED DOSE COMINATION IN DEVELOPMENT OF DISPERSIBLE TABLETS OF TOLFENAMIC ACID AND PARACETAMOL
Abstract
A fixed dose combination (FDCs) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. FDCs are the current hot topic of deliberations in the pharmaceutical industry, government (as regulators), NGOs and the pharmaceutical trade. Migraine is one of the most frequent disabling neurological conditions, which also impact the quality of life. There are server fixed dose combination are available in the treatment of migraine but having its own limitations. Existing fixed dose combination of Acetyl salicylic acid and caffeine is not recommended for pediatrics due to side effect of opoids in caffeine. Tolfenamic acid (TA) is one of the classes of non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat the symptoms of migraine. Paracetamol (4'-hydroxyacetanilide, N-acetyl p- aminophenol, acetaminophen, PAR) is a widely used over-the-counter analgesic and antipyretic drug without any gastric irritation and ulcerative effects. The combination of Paracetamol with Tolfenamic acid can be used as next choice of drug due to lower side effects both the actives. The current research work was set to formulate a dispersible Tablets of Tolfenamic Acid and Paracetamol with application of solid dispersion and co-micronization for solubility enhancement and polymer coating for better taste masking. Various formulations of FDCs were manufactured by using different disintegrants than taste masked by applying a thin layer of polymer coating. The formulation was than evaluated for various physical and analytical properties of dispersible tablets. Results obtained showed that there was a significant impact of disintegrants, and application of solubility enhancement by solid dispersion and co micronization used during formulation of FDCs. The comparative evaluation of formulation A-2 with Crospovidone as disintegrant other formulations also showed better and acceptable organoleptic properties.DOI
https://doi.org/10.22270/jddt.v3i2.459
Published
2013-03-14
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ANAND C. CONCEPT OF FIXED DOSE COMINATION IN DEVELOPMENT OF DISPERSIBLE TABLETS OF TOLFENAMIC ACID AND PARACETAMOL. J. Drug Delivery Ther. [Internet]. 2013 Mar. 14 [cited 2026 Apr. 30];3(2). Available from: https://www.jddtonline.info/index.php/jddt/article/view/459
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How to Cite
1.
ANAND C. CONCEPT OF FIXED DOSE COMINATION IN DEVELOPMENT OF DISPERSIBLE TABLETS OF TOLFENAMIC ACID AND PARACETAMOL. J. Drug Delivery Ther. [Internet]. 2013 Mar. 14 [cited 2026 Apr. 30];3(2). Available from: https://www.jddtonline.info/index.php/jddt/article/view/459
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