31. March 2016

Presentation - James E. Polli University of Maryland Background Prior human in vivo studies Recent series of in vivo human studies of 14 common excipients Potential transporter (or enzyme or nuclear receptor) x excipient interaction concern Conclusions

31. March 2016

Abstract We previously concluded that 12 common excipients need not be qualitatively the same and quantitatively very similar to reference for Biopharmaceutics Classification System–based biowaivers. This conclusion for regulatory relief is based upon a series of bioequivalence studies in humans involving cimetidine and acyclovir. Limitations were also discussed. We understand the major concern of García-Arieta et al. is that “results obtained by Vaithianathan et al. should not be...

31. March 2016

The objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on Biopharmaceutics Classification System (BCS) class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs across three separate four-way crossover bioequivalence (BE) studies (n ¼ 24 each) in healthy human volunteers, denoted as study 1A, 1B, and 2. In study 1A and 1B, three capsule formulations of each drug were manufactured, collectively involving 14...

31. March 2016

March 30, 2016 Home | About | Join | Reference Center | Member Resources Subscribe | Archive | Advertise Search Past Issues | View Web Version | Advertise Search Past Issues View Web Version Advertise Search Past Issues View Web Version Advertise TOP NEWS IPEC Europe Publishes 'How To' Document to Implement 'Guidelines of 19 March 2015 on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use' IPEC-Americas...

30. March 2016

Guy Tiene, Director of Strategic Content, That's Nice LLC/Nice Insight, discusses excipient market trends, the use of excipients to improve the poor aqueous solubility of increasingly complex drug candidates and how drug developers choose excipient suppliers. More

30. March 2016

Objectives. The increasing illegal and on-line market of medicines and food supplements is helping the widespread diffusion of harmful counterfeit and forbidden products among consumers of developed countries. The objectives of this survey were the description of the main frauds recognized by public officers and the detection of illegal or counterfeit drugs and food supplements. Methods. Medicines and food supplements found by Police forces on the illegal market or resulting from seizures made...

30. March 2016

A pharmaceutical compound was used to study the effect of batch wet granulation process parameters in combination with the residual moisture content remaining after drying on granule and tablet quality attributes. The effect of three batch wet granulation process parameters was evaluated using a multivariate experimental design, with a novel constrained design space. Batches were characterised for moisture content, granule density, crushing strength, porosity, disintegration time and...

30. March 2016

Objectives The objective of this study was to evaluate the compatibility of 10 commonly used active pharmaceutical ingredients (APIs) compounded in oral suspensions using a globally available suspending vehicle (SyrSpend SF PH4 liquid): caffeine 10.0 mg/mL, carvedilol 1.0 mg/mL, clomipramine hydrochloride 5.0 mg/mL, folic acid 1.0 mg/mL, hydrochlorothiazide 5.0 mg/mL, loperamide hydrochloride 1.0 mg/mL, methotrexate 2.5 mg/mL, nadolol 10.0 mg/mL, naltrexone hydrochloride...