Topic

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Articles

Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms. 

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Sunday Ndiana-Abasi is an intern pharmacist at the Department of Pharmaceutical Technology and Raw Materials Development in the National Institute for Pharmaceutical Research and Development in Nigeria.

Marlene Ekpo is a youth corp pharmacist and research assistant at the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development, and a postgraduate student at the School of International Education, Southern Medical University, Guangzhou, Guangdong, China.

Martins O. Emeje, martinsemeje@yahoo.com, is a professor at the Department of Pharmaceutical Technology and Raw Materials Development and director of the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery System

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

Grouping Products and Equipment for a Worst-Case Cleaning Validation Study

Dharmang Pandya is Assistant Professor at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa- 388421, Gujarat, India.

Pushti Gandhi is Research Scholar at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa- 388421, Gujarat, India.

Rajesh Parikh is Director at Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar Campus, Nr. Government Polytechnic K-6 Circle, Sector - 26, Gandhinagar-382028, Gujarat, India.

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.

Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene Hydrochloride

Rajendra Kotadiya is assistant professor at Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Changa, Gujarat, India.

Krunal Jasani is PG student at Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Changa, Gujarat, India.

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.

Using Quality by Design to Develop Fixed-Dose Combination Tablets 

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data. 

Determining the Best Estimate of Probability of Passing Multiple Stage Tests:  Part 1–Content Uniformity

, rmontes@alnylam.com, director of CMC Statistics, Process, and Analytical Sciences at Alnylam Pharmaceuticals, Cambridge, MA, has more than 20 years of experience in the bio/pharmaceutical industry. He received his PhD in Chemical Engineering (ChE) from the Georgia Institute of Technology, his MSChE from Texas Tech University, and his BSChE from St. Louis University.

This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products. 

Comparing Methods for Determining Out-of-Trend Stability Test Results

Matthew D. Tandy, PhD,* mtandy@xenon-pharma.com, is associate director of chemistry, manufacturing, and control; Xenon Pharmaceuticals Inc., 200-3650 Gilmore Way, Burnaby, BC, Canada.
*to whom all correspondence should be addressed.

Jay A. Cadieux, PhD, is vice-president of product development & operations; Xenon Pharmaceuticals Inc., 200-3650 Gilmore Way, Burnaby, BC, Canada.

Rostam Namdari, PhD, is senior director of translational drug development, Xenon Pharmaceuticals Inc., 200-3650 Gilmore Way, Burnaby, BC, Canada.

The epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children. 

Using Modified QbD to Develop a Novel Pediatric Formulation of Ezogabine

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS. 

Peer-Reviewed Research