Topic

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.

Articles

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. 

Fabrication Modulation of Zein-based Fibers for Oral Delivery of Hydrochlorothiazide

The authors compare formulations containing citrate with other buffers in reducing subcutaneous injection-site pain and discuss a formulation and excipients selection strategy.

Approaches to Alleviating Subcutaneous Injection-Site Pain for Citrate Formulations

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.

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.


Determining the Probability of Passing USP Content Uniformity and Dissolution (Immediate and Extended) Tests with CuDAL-Excel

Richard Durham is chemistry, manufacturing and control (CMC) quality liaison with Metrics Corp.

Jerry Neal is senior analytical chemist with Metrics Corp. 

Jerry Mizell is director of analytical services at Metrics Corp. 

Matt Casteen is team leader with Metrics Corp. 

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

Identifying the Structure of an Unknown Impurity in a Topical Gel

Robert Shaw is principal scientist statistics, Oral Product Development, Operations, AstraZeneca Pharmaceuticals, Macclesfield, Cheshire, United Kingdom, SK102NA, Robert.Shaw@astrazeneca.com. 

Marie South is associate director, Discovery Sciences Statistics, AstraZeneca Pharmaceuticals, Alderley Park, Cheshire, United Kingdom, SK104TG (until 2015).

The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.

Implementation of Autocorners Algorithm for Retrospective Process Monitoring

Donald A. Johnson, PhD, RAC is senior scientific advisor at Eurofins BioPharma Product Testing.

This paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.

Quantitative Rupture Testing of Soft Gelatin Capsules: Understanding Aberrant Results

The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.

Development of Taste-Masked Oral Reconstitutable Suspension of Cetirizine Dihydrochloride

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

Peer-Reviewed Research