FUNCTIONALITY ADVANCEMENT OF POORLY SOLUBLE BIOVARIABLE ANTI HYPERTENSIVE DRUG BY SOPHISTICATED SD-FBP TECHNOLOGY AS PER ENHANCED QbD
Journal Title: International Journal of Research and Development in Pharmacy & Life Sciences (IJRDPL) - Year 2012, Vol 1, Issue 2
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.
Authors and Affiliations
Amit Mukharya| Formulation Development (F&D) Department, Regulated Market, CADILA Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Pin: 387 810, Gujarat, India, ShivangChaudhary| Formulation Development (F&D) Department, Regulated Market, CADILA Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Pin: 387 810, Gujarat, India, NiyazMansuri| Formulation Development (F&D) Department, Regulated Market, CADILA Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Pin: 387 810, Gujarat, India, Arun Kumar Misra| Formulation Development (F&D) Department, Regulated Market, CADILA Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Pin: 387 810, Gujarat, India
Keywords
Related Articles
- EP ID EP15982
- DOI -
- Views 431
- Downloads 33
Formulation and characterization of mouth dissolving mucoadhesive buccal film of Zolmitriptan
Fast dissolving buccal film drug delivery system is an alternative to tablets, capsules, and syrups for pediatric and geriatric patients who experience in difficulties of swallowing traditional oral solid dosage forms....
Preparation and evaluation of Maltodextrin based Proniosomes containing Capecitabine
Maltodextrin based capecitabine proniosomes were fabricated by conventional slurry method with different surfactant: cholesterol molar ratio keeping constant capecitabine and dicetyl phosphate concentration. The fabric...
In-vitro evaluation of Anti-bacterial and Anti-fungal activity of different Explant extracts of Thespesia populnea L.
Antibacterial and antifungal activity of leaf, bark, flower and seed extracts of Thespesia populnea L.was investigated. The antibacterial activity and antifungal activity was tested against both gram-positive and gram-...
EVALUATING MANAGEMENT SKILLS OF HEAD NURSES OF ZAHEDAN MEDICAL SCIENCES UNIVERSITY TRAINING HOSPITALS BY 360 DEGREES METHOD
In traditional method of evaluating hospitals head nurses’ capabilities like professionalism, communicational skill and interpersonal skill has been performed just by hospitals managers and without taking feedback fro...
A COMPARATIVE STUDY OF BUPIVACAINE AND FENTANYL - BUPIVACAINE IN LOWER ABDOMINAL SURGERY UNDER EPIDURAL ANESTHESIA
Background: Fentanyl is an opioid general anaesthetic acting through the opioid receptors. Combination with local anaesthetics increases the onset and duration of analgesia. The present study compared the efficacy profi...