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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.

Articles

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. 

The Value of Pharmacopeial Reference Standards

Parth Soni is assistant manager, Development Consulting and Scientific Affairs, PharmaLex India, Noida, India.

Sebastian Joseph is principal consultant, director, Development Consulting and Scientific Affairs, PharmaLex India, Noida, India.

To restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.

ECHA’s Microplastics Use Restriction—Impact on Pharmaceuticals

Nasser Nyamweya, PhD*, nasser04@yahoo.com, is a Director at Pharma Manufacturing Solutions. He was previously a Lecturer at the School of Pharmacy, University of Nairobi.

Samantha Kimani is a Pharmacist (B.Pharm) and recently graduated from the University of Nairobi.



This paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.

Chewable Tablets: A Review of Formulation Considerations

Parul Angrish is pharma marketing manager with Agilent Technologies, Inc.

Chander Mani is application engineer with Agilent Technologies, Inc.

Saikat Banerjee is application and business manager for LCMS with Agilent Technologies, Inc.

This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.



Development of a  Validated Method of  Testing for NDMA in Ranitidine 

Sandeep S. Zode, sandipzode@gmail.com; 91-805-406-4151, completed his PhD at the National Institute of Pharmaceutical Education and Research, Department of Pharmaceutics, in Punjab, India. He currently works as a senior research scientist in formulation development at Fresenius Kabi India Pvt. Ltd., Gurugram, India.

Rajesh Patil, PhD, is currently pharmaceutical development leader at Elanco, formerly a division of Eli Lilly & Company, IN.

Piyush Gupta, PhD, is now associate director & lead, pharmaceutics, for Biocon Bristol-Myers Squibb R&D Center (BBRC), Bristol-Myers Squibb India Pvt. Ltd., Bengaluru, India.

Rajasekhar Jaladi, PhD, jaladi.rajasekhar@gmail.com is associate vice president, drug metabolism and pharmacokinetics, for proprietary products, at Dr. Reddy’s.

Anirudh Gautam is senior director of R&D, Dr. Reddy’s Switzerland.

Rajeev Singh Raghuvanshi, PhD, is senior vice president at Dr. Reddy’s Laboratories Ltd

Research suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.


Assessment of Nanosuspension Formulation for Intranasal Administration

Esra’a Albarahmieh is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Mohammad Khanfar is associate professor, Pharmaceutical Chemical Engineering department of the School of Applied Medical Sciences, German Jordanian University.

Emad Alzubi is instructor and workshop manager at the Industrial Engineering department of the School of Applied Technical Sciences, German Jordanian University.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs. 

Peer-Reviewed Research