Title: Hot melt extrusion an emerging drug delivery technology of 21st Century.

Abstract:

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. It is a fast growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, high degree of automation, absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in pharmaceutical industry continues to grow and recent success of this technique have made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability. The utilization of hot-soften expulsion (HME) inside the pharmaceutical business is consistently expanding, because of its demonstrated capacity to productively make novel items. The procedure has been used promptly in the plastics business for longer than a century and has been utilized to make clinical gadgets for a very long while. The improvement of novel medications with poor dissolvability and bioavailability brought the use of HME into the domain of medication conveyance frameworks. This has explicitly been appeared in the advancement of medication conveyance frameworks of both strong dose structures and transdermal patches. HME includes the utilization of warmth, weight and tumult through an expulsion channel to combine materials, and along these lines driving them out through a kick the bucket. Twin-screw extruders are generally well known in strong measurement structure advancement as it gives both dispersive and distributive blending. It mixes materials while additionally granting high shear to separation particles and scatter them. HME expulsion has been appeared to molecularly scatter ineffectively dissolvable medications in a polymer bearer, expanding disintegration rates and bioavailability. The most widely recognized trouble experienced in delivering such scatterings is adjustment of shapeless medications, which keeps them from recrystallization during capacity. Pharmaceutical mechanical providers, of the two materials and gear, have expanded their improvement of hardware and synthetic concoctions for explicit use with HME. Unmistakably, HME has been distinguished as a significant and huge procedure to additionally upgrade tranquilize solvency and strong scattering creation. The pharmaceutical improvement of nebulous strong scatterings (ASDs) by hot-liquefy expulsion (HME) is quickly evaluated. A deliberate bit by bit approach is introduced, where thermodynamics, polymer screening, multivariate measurements and procedure enhancement are consolidated, to expand the accomplishment of HME-based medication item advancement. The quality by structure (QbD) idea is acquainted and applied with HME. Steps and devices for its successful execution are given, including hazard evaluation featuring pivotal focuses. The specialized and logical specificities of HME-based ASDs are talked about considering the current worldview of medication advancement and in-accordance with administrative rules from the ICH areas. Contextual investigations of as of late affirmed HME items are introduced. Pharmaceutical improvement expects to give vigorous information through the utilization of deliberate methodologies that permit planning a quality item and its assembling procedure reliably. The data and information gathered from improvement and creation ought to give the logical comprehension to help a plan space, sedate item particulars and procedure controls. The total comprehension of the plan and procedure is united in the Common Technical Document and afterward used to present another medication application to the capable specialists . In HME-based medication items, a powerful pre-definition appraisal is the way in to a fruitful turn of events. A bit by bit approach, beginning with the thermodynamic assessment of a few frameworks, trailed by a polymer screening test combined with multivariate measurable investigation, is helpful to quickly recognize the most encouraging HME frameworks. This is the best approach to abstain from sitting around idly, cash and exertion in bombed synthesis

Biography:

Rashid Mahmood has master degree in analytical chemistry and MS in total quality management. He has 15 years of experience of pharmaceutical quality operations and has participated in many international conferences as a keynote speaker. He has presented various talks in USA, Canada, UK & UAE on cleaning validation, cGMP guidelines, quality risk management,role of mass spectrometry in pharmaceuticals and on new drug delivery dystems. Currently he is working as a General manager technical operations for Surge Lab. which is the best export oriented company of pakistan..