Irrational Fixed dose combinations: Awareness must for Pharmaceutical manufacturers & marketing companies
Irrational Fixed-dose combinations: Awareness must for Pharmaceutical manufacturers & marketing companies
Combination products, also known as fixed-dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance
The rationality of FDCs should be based on certain aspects such as
- The drugs in the combination should act by different mechanisms.
- The pharmacokinetics must not be widely different.
- The combination should not have the supra-additive toxicity of the ingredients
Some irrational fixed-dose drug combinations available
Norfloxacin + Metronidazole; Norfloxacin + Tinidazole; Norfloxacin + Tinidazole + Loperamide; Norfloxacin + Tinidazole + Dicyclomine
Irrationality
Though claimed to be broad spectrum, combining (antiamoebic) with a fluoroquinolone (antibacterial) is irrational because patient suffers only from one type of diarrhoea. Using this combination adds to cost, adverse effects and may encourage resistance.
Nimesulide + Diclofenac; Nimesulide + Dicyclomine + Simethicone; Nimesulide + Paracetamol; Nimesulide + Cetirizine + Pseudoephedrine; Nimesulide + Paracetamol + Tizanidine
Irrationality
Combining two NSAIDs may increase the side effects of both the NSAIDs. There is little documentary evidence that a preparation containing more than one analgesic is more effective than a single ingredient preparation.
Cisapride + Omeprazole; Mosapride + Pantoprazole ; Ondansetron + Pantoprazole
Irrationality
In patients with gastroesophageal reflux disease, the use of this combination has shown no benefit due to the addition of prokinetic drugs.
In the last few years, pharma marketing business & number of companies has grown manifold, so many of the companies are opting for third-party manufacturing of their product. The tendency is to bring new formulations specifically fixed-dose combinations without making much effort on research & development of such formulations. It is utmost important to aware all the stakeholders about the merits and demerits of fixed-dose combinations. Regulatory knowledge of various studies required to establish safety and efficacy of these combinations and strict compliance to such regulation is must for all the stakeholders.
Notification of banned compositions 10-March 2016
http://www.cdsco.nic.in/writereaddata/SO%20705(E)%20TO%201048(E)%20DATED%2010-03-2016.pdf
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3117572/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2432494/
http://medind.nic.in/ibi/t06/i3/ibit06i3p169.pdf
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