Functionality advancement of poorly soluble biovariable anti hypertensive Drug by sophisticated SD-FBP technology as per enhanced QbD.

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Date
2012-06
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Abstract
Lacidipine (LCDP) is a dihydropyridine derivative categorized as an Anti-hypertensive Ca+2 channel blocker belonging to BCS class IV drug with low solubility and low permeability which presents a challenge to the formulation scientists. The development of a solid dispersion by solvent evaporation is a practically viable method to enhance dissolution of LCDP from oral dosage form. Solvent evaporation by Fluidized Bed Process (FBP) was the method of choice for SD as it improves wettability with simultaneous increase in porosity of granules resulting enhanced surface area producing higher dissolution rate and bioavailability of poorly water-soluble drug. Thus, the main object of the present invention is to provide stable pharmaceutical dosage form of LCDP with desired dissolution rate i.e. at least 80% drug release within 45 minutes, without use of disintegrant(s) and/or surfactant(s) or without micronization of the active ingredient per se. One more object of this invention is to provide a sophisticated robust process for the preparation of said pharmaceutical dosage form by Quality by Design (QbD) concept focusing on thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing by IRMA & FMEA study of the product with process and how best to mitigate those risks by developing design space with DoE & MVDA with outlined control strategy.
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Lacidipine (LCDP), Solid Dispersion (SD), Fluidized Bed Process (FBP), Critical Quality Attribute (CQA), CPP (Critical Process Parameter), Failure Mode Effective Analysis (FMEA), Design of Experiment (DoE),, Quality by Design (QbD)
Citation
Mukharya Amit, Chaudhary Shivang, Mansuri Niyaz, Misra Arun Kumar. Functionality advancement of poorly soluble biovariable anti hypertensive Drug by sophisticated SD-FBP technology as per enhanced QbD. International Journal of Research and Development in Pharmacy and Life Sciences. 2012 Jun-Jul; 1(2): 72-89.