An Overview of Industrial Process Validation of Tablets

Abstract

Product quality is the mainstay of pharmaceutical industries and is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Process validation is an integral part of quality assurance program in industries. By validating each step of production process we can assure that the final product is of best quality. This review provides information on objectives and benefits of process validation, types of process validation, major phases in validation and regulatory aspects. Guidelines and strategy for process validation of solid dosage form are also discussed.

Methoxy-modified kaolinite as a novel carrier for high-capacity loading and controlled-release of the herbicide amitrole

“…This result suggests that the diffusion-restriction of the lamellar structure of kaolinite is even more excellent than the tubular structure of halloysite, which endows the methoxy-modified kaolinite with a controlled-release property. Additionally, it can be anticipated that this controlled-release property could be readily further promoted using a combination of some other techniques, such as commonly used tabletting 35 and coating techniques 27 29 .…”

Topical gel of Metformin solid lipid nanoparticles: A hopeful promise as a dermal delivery system

“…In another study, Sharma et al prepared Met-loaded solid lipid nanoparticles for transdermal delivery by solvent diffusion technique. The particle size, zeta potential and percentage drug entrapment for their optimized SLN were 242±5, +27 mV and 94.62±0.02 % respectively [22]. The advantage of the current method used to prepare Met-SLN over other published method is that no organic solvent was used, and the nanoparticles were incorporated into the gel base which could be a finished product.…”

“…et al also showed that the miconazole nitrate -SLN gel could significantly increase the accumulative uptake of miconazole nitrate in the skin over the marketed gel and showed a significantly enhanced skin targeting effect[25]. Sharma et al also showed that the high cumulative amount of Met is permeated from Met SLN transdermal patches[22]. The results obtained from in vitro percutaneous absorption in the present study indicated that lipid nanoparticles gel are promising in local delivery for Met and other hydrophilic drugs and stimulating new and deeper investigations in the field.…”

Tablet Granulation: Current Scenario and Recent Advances

“…The primary powder particles are aggregated under high pressure. There are two main processesi) Slugging-Either a large tablet known as a 'slug' is produced in a heavy-duty tabletting press 12 .…”