17. August 2018
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100 raw material descriptors related to particle size and shape distribution, specific surface area, bulk, tapped and true density, compressibility, electrostatic charge, moisture content, hygroscopicity,...
14. June 2018
The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the...
27. August 2017
Pharmaceutical dosage forms address diverse key components but satisfying unmet patient needs to enhance patient adherence is a major challenge. The desired design of patient-centered drug products should be based on characteristics of various components, such as patients, disease, routes of administration, drug delivery technologies and active pharmaceutical ingredients.
14. December 2016
Purpose: To validate a new and simple method for cleaning a manufacturing line for creams and ointments. Methods: The worst case product of the line chosen was a cream containing three practically insoluble ingredients: betamethasone, tolnaftate and cliquinol. The cleaning method utilized hot water and a commercial detergent, followed by rinsing. Validation methods included the visual inspection of the machine surface, swab sampling, microbial bioburden determination and testing the final rinse...
24. June 2016
Abstract The term “patient centered,” “patient centric,” or “patient centricity” is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient’s quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that...
22. March 2016
An increasing elderly population is leading to a change in the global demographics. This presents a new challenge to society and the pharmaceutical industry. This demographic shift is providing an opportunity for the pharmaceutical industry to meet the specific needs of the changing patient population. One issue that has been identified is defining what is meant by “an older patient”, since this definition cannot be simply limited to chronological age. The fundamental purpose of the design...
17. January 2016
This study aimed to design a fixed-dose combination dosage form which provides a sustained release profile for both the freely water-soluble metformin HCl and the poorly soluble gliclazide, two antidiabetic compounds used to treat diabetes mellitus. More
07. December 2015
It is rare to have a pharmaceutical dosage form presented with just the pure active pharmaceutical ingredient because the drug substance does not possess adequately desirable physical attributes to be processed into the final dosage form. Consequently, additives or excipients which are inert ingredients serving a functional purpose are added to enhance the overall properties of the final formulation for ease of processability or drug product performance. More
07. November 2015
IPEC Presentation by Meera Raghuram Manager, Global Regulatory Affairs and Strategies – Lubrizol LifeSciences Chair – Regulatory Affairs Committee, IPEC-Americas Link