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Building a Quality by Quality by Design (QbD) and Quality Culture

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The quality of a product does not occur on its own. People throughout an organization do not always carry out instructions or perform their role correctly. It is the continuing task of quality management to deal with this situation and ensure that all members of the industrial team are aware of their quality responsibilities and are accountable for their actions. Quality must be designed into products– discipline, attitude and inventiveness must be encouraged to create easy to make and easy to use fool proof products. Quality must then be planned into manufacture – methods must be devised so that the easiest way to do the job is the right one; so that, where appropriate, worker interest is created; and elsewhere complete control is built into the process. Finally, quality must be built into the product– the people concerned with the cutting, fitting and assembling must be well trained and enthusiastically led to achieve “right first time” production. This is the simple overall formula,

Oral disintegrating tablets (ODTs): A new trend in drug delivery

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  ABSTRACT The most common and preferred route of drug administration is through the oral route. ODTs are gaining importance among novel oral drug-delivery system as they have improved patient compliance and have some additional advantages compared to other oral formulation. They are also solid unit dosage forms, which disintegrate in the mouth within a minute in the presence of saliva due to super disintegrants in the formulation. Thus, this type of drug delivery helps a proper peroral administration in pediatric and geriatric population where swallowing is a matter of trouble. Various scientists have prepared ODTs by following various methods. However, the most common method of preparation is the compression method. Other special methods are molding, melt granulation, phase-transition process, sublimation, freeze-drying, effervescent method, cotton candy process, mass-extrusion etc. Since these tablets dissolve directly in the mouth, so, their taste is also an important factor. Vario

Fundamental aspect of super disintegrants: A concise review

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ABSTRACT Super disintegrants (SDTs) are the class of compounds which primarily aid in the solid dosage forms for the rapid disintegration. This class of disintegrants have been shown to be effective at excipient concentrations as low as 1 to 10% when compared to traditional disintegrant starches, which may need concentrations as high as 20%. To date there have been three primary classes of modified starch used as SDTs in the formulation of solid dosage forms: sodium starch glycolate (SSG), croscarmellose sodium (CCS), and synthesized polymer crospovidone (XP). The inclusion of the right super disintegrant is a prerequisite to get optimal bioavailability in tablets and capsules which need rapid disintegration. Super disintegrants are used to improve the efficacy of solid dosage forms. This is achieved by decreasing the disintegration time which in turn enhances the drug dissolution rate. Keywords: super disintegrants, croscarmellose sodium, sodium starch glycolate, crospovidone, swellin