Tablets Capsules

TC0618_SB

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coating two film coating systems Sensient Pharmaceutical Th Th T is article describes a stu tu t dy dy d that compare re r d tw tw t o coating ng n sy sy s s- MC b d d h h A b d Th Th T film quality, good product stability, and an economical application process. Rheology testing provides a useful h if i h fil ' i d Check out Tablets & Capsules' article archive. tabletscapsules.com (enter username & password or click register) D tems, one HP HP H M PM P C-based and the other PVA VA V -based. Th Th T e com- parison gaug ug u ed how well each coating ng n re re r sisted photo and ther- mal deg eg e radation and how their gloss, slip, and adhesion responded to chang ng n es in exhaust tempera ra r ture and spra ra r y ra ra r te. Cost implications are re r also discussed. D e D v D e D l D o D o D ping a film coating is similar to developing a dru D u D g D p D r D o D o D du du d ct. Both require process understanding and con- tro D o D l D . D B D o D t D t D h require specify fy f ing and defining the process at the D e D d D d D e D e D v D v D e D e D lopment stage. Both require, for business reasons, a definition of their critical quality attributes (CQA QA Q s) as early as possible du du d ring development. Furthermore, in both cases, how well the produ du d ct meets the target CQA QA Q s will largely determine how well it sells, how profitable it is, and how long its life-cycle is likely to be. The CQAs of coatings include excellent color, high fil lit d d t t bilit d i l approach to quantify fy f ing how a film's properties respond to changes in the process and/ d/ d or changes in the product's environmental exposure. Systematic process testing can also increase process understanding, which contributes to better process control and better product quality control. These same methods can also be used to compare prod- ucts. Furthermore, by using a systematic, matrix-based design-of-testing (also known as a design-of-experiment, or DOE) approach, it's possible to eliminate inconclusive interpretations of the data. In this way, the significant effects of the process variables can be identified and used to determine how sensitive the process is to changes and how tolerant the product is of change, often called robustness. The methodology can also reveal the process specification, one that keeps the process in control and lowers the risk of deviations. This article discusses a Qu Qu Q ality-by-Design study dy d that Popular topics: Capsules & capsule filling Tablets & tableting Excipients Analytical techniques Dietary supplements Formulation Granulation coating A Quality-by-Design comparison of Brian Cheng S P Looking for past articles?

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