28. February 2017
ABSTRACT: The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that publishes monograph standards for identification and testing of drug products, excipients, foods and dietary supplements, among other related products. USP’s monographs and over 3500 reference standards are used in more than 140 countries for regulatory and industry quality control. Supported by FDA and by public and industry outreach efforts, the USP monograph Up-to-Date initiative continues to...
28. February 2017
ABSTRACT: Know about the first organic bitter blocker, ClearTaste™, which is derived from a mushroom fermentation process. ClearTaste is capable of mitigating bitter, astringent and sour off tastes from a wide variety of applications. For Pharma applications, It is particularly effective in high intensity sweeteners, vitamins, and supplements to name a few. By eliminating the perception of the flavor defects, formulators can drastically reduce or eliminate the sugar requirements in their...
28. February 2017
Abstract The objective of the present investigation was to understand the effects of excipients and curing process on the abuse deterrent properties (ADP) of Polyox™ based directly compressible abuse deterrent tablet formulations (ADFs). The excipients investigated were lactose (monohydrate or anhydrous), microcrystalline cellulose and hydroxypropyl methylcellulose. The ADPs studied were tablet crush resistance or hardness, particle size distribution following mechanical manipulation, drug...
28. February 2017
BY: ASHLEY JOHNSON Recently, there has been increasing interest in using 3D printing (3DP) to manufacture drug products. Notably, in 2015, the Food and Drug Administration (FDA) approved the first 3D printed tablet, Aprecia Pharmaceutical’s Spritam for the treatment of epileptic seizures. Spritam is fabricated using the company’s ZipDose 3DP technology, which creates porous tablets that dissolve almost instantaneously in the mouth. In 2016, FDA released draft guidance for submission of...
27. February 2017
ABSTRACT: Docusate, a surfactant for the pharmaceutical market, has been demonstrated to be an outstanding solubilizing agent for poorly soluble API’s while providing additional processing benefits in drug formulation. DocuSolv™s are new forms of Docusate which have been developed to overcome handling issues with Docusate. They are granular, free flowing forms of Docusate with fine particle size which dissolve significantly faster and additionally have higher solubility than Docusate...
27. February 2017
Abstract Mycophenolate mofetil is used as an immunosuppressive agent to prevent acute rejection of transplanted organs. Mycophenolate mofetil is rapidly absorbed following oral administration and hydrolysed by esterases in the liver and kidney to its active metabolite, mycophenolic acid, a selective and reversible inhibitor of inosine monophosphate dehydrogenase. Due to the clinical advantages of mycophenolate mofetil, there has been an increase in the number of mycophenolate mofetil...
27. February 2017
The drastic development of polymeric materials for a wide range of biomedical and biomaterial applications has been explored in the last few decades. Among these materials, a new class of ‘smart’ or ‘intelligent’ biomaterial has been developed, and these materials are highly responsive to slight changes in their environments. Due to their dynamically alterable properties, smart materials allow for smart biomaterials to be developed. This review presents smart thermo-responsive polymers...
27. February 2017
Abstract The 3D printing technique of fused deposition modeling® (FDM) has lately come into focus as a potential fabrication technique for pharmaceutical dosage forms and medical devices that allows the preparation of delivery systems with nearly any shape. This is particular promising for implants administered at application sites with a high anatomical variability where an individual shape adaption appears reasonable. In this work different polymers (Eudragit®RS, polycaprolactone (PCL),...
27. February 2017
Abstract Micronized cocrystal powders and amorphous spray-dried formulations were prepared and evaluated in vivo and in vitro as pulmonary absorption enhancement formulations of poorly soluble itraconazole (ITZ). ITZ cocrystals with succinic acid (SA) or l-tartaric acid (TA) with a particle size diameter of <2 μm were successfully micronized using the jet-milling system. The cocrystal crystalline morphologies observed using scanning electron microscopy (SEM) suggested particle shapes that...
27. February 2017
Abstract We have reported that cell-penetrating peptides, such as oligoarginine, act as powerful absorption enhancers for the development of oral insulin delivery systems. However, the minimal essential sequence of oligoarginine that stimulates intestinal insulin absorption remains unclear. Therefore, the present study was conducted to clarify this minimum sequence of oligoarginine and to examine the effect of single cationic amino acid arginine on the intestinal and oral absorption of insulin....