26. November 2016

Dear followers of pharma-excipients.ch and pharma excipients linkedin group, The pharma-excipients blog will be silent for the next 2 weeks and back on track December 12, 2016 with updates of the missed time and new articles. In the meantime don't miss to check the different topics on pharma-excipients.ch including the article archive which covers the last years of blogs posted. Archive Excipient Manufacturers Services Providers Information Sources (Reports, DMF List, ExciPact Supplier List,...

24. November 2016

Misuse and Abuse of Prescription Drugs Prescription pain relievers are safe and effective when used correctly for a medical condition and under a doctor’s supervision. But they can cause serious side effects if not used correctly. Incorrect use or use for non-medical reasons can lead to abuse, addiction and even death1). SAMHSA recently reported results from their 2014 Survey on Drug and Health2). About 4.3 million people age twelve and older reported nonmedical use of prescription pain...

24. November 2016

Abstract The use of fixed dose combination (FDC) drug therapies has been world-widely accepted for long years due to providing better disease treatment with enhanced therapeutic efficacy and safety as well as improved patient compliance and adherence, and reduced cost to patients than single drug therapies. From many different perspectives, the development of FDC products is likely a promising approach to achieving clinical benefits and business advantages in many classes of drugs. The...

22. November 2016

INTRODUCTION In recent years, the use of 3D printing (3DP) for formation of custom dose forms has received increasing research interest for pharmaceutical applications. To date limited API loadings have been achieved. Current fused deposition modelling (FDM) approaches utilise a formulated filament (e.g. polymer and active) as a feedstock which can be made by hot-melt extrusion (HME). One key purpose of this work is to explore methods of achieving developing a viable routes to establishing...

22. November 2016

Abstract Gastrointestinal drug administration is the preferred route for the majority of drugs however, the natural physiology and physicochemistry of the gastrointestinal tract is critical to absorption but complex and influenced by factors such as diet or disease. The pharmaceutical sciences drive for product consistency has led to the development of in vitro product performance tests whose utility and interpretation is hindered by the complexity, variability and a lack of understanding. This...

22. November 2016

Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with...

22. November 2016

Efforts at elimination of scourges, such as malaria, are limited by the logistic challenges of reaching large rural populations and ensuring patient adherence to adequate pharmacologic treatment. We have developed an oral, ultra–long-acting capsule that dissolves in the stomach and deploys a star-shaped dosage form that re- leases drug while assuming a geometry that prevents passage through the pylorus yet allows passage of food, enabling prolonged gastric residence. This gastric-resident,...

22. November 2016

Abstract The parameters affecting the recovery of pharmaceutical residues from the surface of stainless steel coupons for quantitative cleaning verification method development have been studied, including active pharmaceutical ingredient (API) level, spiking procedure, API/excipient ratio, analyst-to-analyst variability, inter-day variability, and cleaning procedure of the coupons. The lack of a well-defined procedure that consistently cleaned coupon surface was identified as the major...

22. November 2016

Elacridar is an inhibitor of the permeability glycoprotein (P-gp) and the breast cancer resistance protein (BCRP) and is a promising absorption enhancer of drugs that are substrates of these drug-efflux transporters. However, elacridar is practically insoluble in water, resulting in low bioavailability which currently limits its clinical application. We evaluated the in vitro dissolution and clinical pharmacokinetics of a novel amorphous solid dispersion (ASD) tablet containing elacridar. The...

22. November 2016

ABSTRACT In the late 1970s, rapid disintegrating drug delivery system was developed as an alternative to capsules, tablets and syrups for geriatric and pediatric patients having problems in swallowing. To overcome the need, number of orally disintegrating tablets which disinte- grate within one minute in mouth without chewing or drinking water were commercialized. Then later, oral drug delivery technology had been improved from conventional dosage form to modified release dosage form and...