S. Lakshmana Prabu

Extraction of Drug from the Biological Matrix: A Review

The assessment of therapeutic compliance is commonly done by either indirect method or direct method. In indirect method, the assessments are done by indirect measurement of parameters such as discussion with patients and pill counts at intervals during the treatment which don’t measure the drug concentration in a matrix such as blood or urine. In direct method, the assessments which rely upon evidence provided by the patients or care giver on the presumptive compliance based upon electronic medical event monitoring system and this is based upon either the qualitative or quantitative measurement of the drug under investigation in a biological matrix provided by the system.

Impact of Microbial Surface Contamination and Effective Environment Monitoring System in Pharmaceutical Manufacturing

The nature of the contaminants and their impact in pharmaceutical manufacturing are discussed. This understanding, prior to pharmaceutical manufacturing operations and application of methods for minimizing such contamination, is vital to preparing for successful manufacturing operations. Good manufacturing/laboratory practices must be followed during product manufacturing to prevent surface contamination. Water, compressed gas, air, surfaces and personnel involved in the manufacturing operations must be monitored to ensure a clean environmental system in the manufacturing areas. Environmental control tests must be performed periodically to ensure that the manufacturing area is free from microbial contamination. A properly designed and maintained disinfection program will provide the pharmaceutical manufacturing areas with an environment relatively free from microorganisms on a consistent basis.

GMP in Pharma Manufacturing—Description of GMP as Related to Air-Handling Units and Prevention of Contamination and Implementation of GMP Regulatory Requirements

Abstract Drug substances and drug products are used for treating various diseases to save the lives of human beings. Drug substances and drug products should be manufactured using clean equipment with appropriate quality and in good environmental condition to avoid contamination of the product and to produce the desired therapeutic effect. Effort should be made to build quality into the product during each stage of the manufacturing process rather than simply testing the product. To regulate the manufacturing process, regulatory agencies along with pharmaceutical industrial organizations developed good manufacturing practice (GMP) guidelines for the preparation/manufacturing of the drug substance and drug products. Various GMP guidelines are followed in respective regions in the world even though the fundamentals of all the guidelines remain the same. The GMP guidelines consist of various processes including quality management, personnel, personal hygiene and qualification, building and facilities, sanitation, documentation and records, material management, production and in-process controls, packaging and labeling of drug substances and drug products, storage and distribution, laboratory controls, validation, rejection and reuse of materials, complaints and recalls, and change control. Clean equipment, cleanrooms, and environmental conditions are critical process parameters to be monitored strictly in the manufacturing process to ensure the highest standard of quality and purity of the product with desired safety and efficacy of the drug product to meet the regulatory requirements.

Design and evaluation of matrix diffusion controlled transdermal patches of coumarin.

The aim of the present investigation was to prepare coumarin matrix transdermal systems using the combinations of Eudragit RL-100/Eudragit RS-100. The formulations were evaluated for various physicochemical properties (thickness, weight variation, drug content uniformity, moisture content and water absorption uptake), in vitro release studies, in vitro skin permeation studies and skin irritation studies. In vitro skin permeation and skin irritation studies were carried out on rat skin and rabbit respectively. The drug-polymer interaction results revealed no interaction between the drug and the polymers. Drug content uniformity of the patches was found more than 98%. Variations in drug permeation profiles were observed among the formulations. From the results concluded that coumarin can be formulated into the transdermal matrix type patches to overcome the first pass effect, reduced frequency of administration of coumarin and sustain its release characteristics; the polymeric composition Eudragit RL and Eudragit RS (1:1) with 1mL of ethanol was found to be the best choice for the formulation of transdermal patches of coumarin among the formulation studied.