February 2016 volume 23 issue 1

Dissolution Model Development: Formulation Effects and Filter Complications

This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Full article

Ragna Berthelsen1 René Holm2 Jette Jacobsen1 Jakob Kristensen3 Bertil Abrahamsson4 Anette Müllertz11,5
1Department of Pharmacy, University of Copenhagen, Denmark
2Biologics and Pharmaceutical Sciences, H. Lundbeck A/S, Copenhagen, Denmark
3cJakob Pharma, Seattle, WA, USA
4AstraZeneca Pharmaceutics, R&D, Mölndal, Sweden
5Bioneer: FARMA, Department of Pharmacy, University of Copenhagen, Denmark
In Vitro Dissolution Curve Comparisons: A Critique of Current Practice

We review previously published work on dissolution profile similarity testing and provide a detailed critique of current methods in order to set the stage for a Bayesian approach. Full article

Dave LeBlond1 Stan Altan2 Steven Novick3 John Peterson4 Yan Shen2 Harry Yang5
1CMC Statistics Consultant, Wadsworth, IL 60083
2Janssen Research & Development LLC, Raritan, NJ 08869
3GlaxoSmithKline Pharmaceuticals, Research Triangle Park, NC 27709
4GlaxoSmithKline Pharmaceuticals, Collegeville, PA 19426
5MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
pH Dependence of the Dissolution Rate of EntericCoated Drug Spheres Determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Enteric coatings are widely used in formulations of drug delivery spheres. The coating protects an active pharmaceutical ingredient (API) from acidic conditions in the low pH environment of the stomach. Full article

Rachel Evans-Hurson1 Seán McSweeney1 Bastiaan Vos1 Jacob Krüse2 J. J. Keating1,3 Dara Fitzpatrick1
1Department of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland
2Kinetox, Beilen, The Netherlands
3School of Pharmacy, University College Cork, Ireland
Modulation of pH-Independent Release of a Class II Drug (Domperidone) from a Polymeric Matrix Using Acidic Excipients

Drug release from polymeric matrix systems is the rate-limiting step for drug bioavailability and is determined by drug solubility; most drugs show pH-dependent solubility. Full article

Amjad Khan1 Zafar Iqbal2 Abad Khan3 Muhammad Akhlaq Mughal2 Abbas Khan2 Zia Ullah2 Ismail Khan2
1Department of Pharmacy, Abasyn University, Peshawar-25120, Pakistan
2Department of Pharmacy, University of Peshawar, Peshawar-25120, Pakistan
3Department of Pharmacy, University of Swabi, Swabi, Pakistan
Influence of Various Media on the Dissolution Profiles of Immediate-Release Quetiapine Tablets in India

Dissolution testing was performed to evaluate the drug release from tablets. To mimic actual in vivo conditions, various foods and beverages were added to the dissolution media, and the release profiles were investigated. Indian people tend to have milk, curds, or eggs during their meals and then take their medications immediately after meals, whereas Americans tend to take medications with beverages. Full article

Zubin Shah1 Vaishali Londhe1
1Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, India
AAPS Focus Group
Meeting Report: AAPS In Vitro Release and Dissolution Testing Focus Group Face-to-Face Meeting

The AAPS In Vitro Release and Dissolution Testing (IVRDT) Focus Group had a Face-to-Face (F2F) Meeting on November 19, 2015, hosted by Bristol-Myers Squibb in New Brunswick, NJ. Xujin Lu (Bristol-Myers Squibb) was the Chair of the Organizing Committee, and the other members were Nikoletta Fotaki (University of Bath), Marie DiMaso (Corealis Pharma), and Vivian Gray (V. A. Gray Consulting). Full article

Vivian Gray1 Xujin Lu2 Jian-Hwa Han3 Dorys Diaz4 Geoffrey Grove5
1Dissolution Technologies, Hockessin, DE, USA
2Bristol-Myers Squibb, New Brunswick, NJ, USA
3AbbVie, North Chicago, IL, USA
4Pfizer, Groton, CT, USA
5Sotax, Westborough, MA, USA
Questions and Answers

Questions have been submitted by readers of Dissolution Technologies. USP experts authored responses to each of the questions.

Margareth Marques1 William Brown1
1U.S. Pharmacopeia, Rockville, MD, USA

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Industry news

Upcoming Audit? Get Prepared with the New Dissolution Workstation

Software The new Agilent Dissolution Workstation software can help you meet your regulatory requirements. This paperless, compliant solution organizes all your dissolution methods and test data while controlling access and preventing unwarranted changes or errors. There’s no easier way to satisfy the necessary requirements for data storage and traceable records than this easy-to-implement software solution. Full article

Expanding In Product Development for Logan Instruments Corp. with Balloon Catheter Instrumentation and More

Somerset, NJ—January 17, 2016—Logan Instruments Corp. has diversified its portfolio through the expanding use of their Disso III-7 instrument. This year Logan Instruments Corp. has worked with customers on the development of instrumentation for the characterization and testing of combination products. With vast engineering knowledge, Logan Instruments Corp. has provided customers with Disso III-7 equipment for the evaluation of balloon catheters without the large cost of reinventing a brand new system. Full article

Pharma Test Announces Acquisition of J&M

Hainburg, Germany—January 2016—Pharma Test Apparatebau AG, a leader in the field of high-quality testing equipment for the pharmaceutical industry, announced today that it has acquired J&M Analytik AG, a German manufacturer and developer of fiberoptic diode-array spectrometer systems for laboratory and process applications. Full article

Hanson Research Announces Three-Year Warranty for Release-Rate Testing Instruments

Los Angeles, CA—February 1, 2016—Hanson Research announced today that it has increased the warranty period on its dissolution testing and diffusion testing instruments from one year to three years at no additional cost for all purchases invoiced and shipped during 2016. The 65th Anniversary Warranty program triples the industry average of one year, and in conjunction with Hanson Research’s global network of service and support professionals, it provides increased peace of mind and greater security for investments in laboratory equipment. Full article

USP Releases Online Database of Dissolution Methods

Rockville, MD-December 16, 2015—The USP Dissolution Methods Database is now available online. The database contains the test conditions (except Tolerances or Acceptance Criteria) as stated in the sections of the United States Pharmacopeia—National Formulary (USP-NF) referring to dissolution, disintegration, or drug release tests in the respective USP drug product monograph. Full article

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