May 2016 volume 23 issue 2

Monitoring Drug Release from Electrospun Fibers Using an In Situ Fiber-Optic System

Electrospun fiber mats are currently gaining attention as advanced drug delivery systems. Dissolution testing for such systems is generally performed in small vials by immersing the fiber mats in buffered solutions. Full article

Salem Seif1,2 Florian Graef3 Sarah Gordon3 Maike Windbergs1,2,3
1Saarland University, Department of Biopharmaceutics and Pharmaceutical Technology, Saarbruecken, Germany
2PharmBioTec GmbH, Saarbruecken, Germany
3Helmholtz Centre for Infection Research (HZI) and Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Department of Drug Delivery (DDEL), Saarbruecken, Germany
Development and Validation of a Discriminating Dissolution Method for Atorvastatin Delayed-Release Nanoparticles Using a Flow-Through Cell: A Comparative Study Using USP Apparatus 4 and 1

Atorvastatin, an HMG CoA reductase inhibitor, is widely used for the treatment of dyslipidemia and prevention of cardiovascular disease. It belongs to Class 2 of the Biopharmaceutics Classification System owing to its low solubility and high permeability. Full article

Sandip Gite1 Manasi Chogal1 Vandana Patravale1
1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N. P. Marg, Matunga, Mumbai, India
Assessment of the Pharmacopeial Analytical Methodologies in the Dissolution Test of Enteric-Coated Lansoprazole Preparations

The performance of the analytical methodologies recommended by the United States Pharmacopoeia (USP) monograph(1) for dissolution testing of lansoprazole (LPZ) enteric-coated solid dosage forms (capsules/tablets) was critically evaluated. Full article

Alaa M. Abu Hammad1 Imad I. Hamdan1 Dina El-Sabawi1
1Faculty of Pharmacy, The University of Jordan, Amman, Jordan
Discriminatory Dissolution Method Development and Validation of Etoricoxib Tablets

The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation in quality by design trials is mandatory for products intended for the developed market. Full article

Yasvanth Ashokraj1 Atul Daroi1 Raja Gupta1 Aruna Khanolkar1 Amol Kulkarni1 Swati Laud1 Milind Pokale1 Sanjeet Shedge1 Praveen Date1
1CIPLA Ltd, Mumbai, India
Evaluation of Pharmaceutical Quality of Conventional Dosage Forms Containing Paracetamol and Caffeine Available in Turkish Drug Market

The aim of this study was to evaluate the quality of conventional paracetamol- (PA) and caffeine- (CA) containing combined dosage forms in the Turkish drug market. Full article

Emrah Akgeyik1 Mustafa Sinan Kaynak1 Mustafa Çelebier2 Sacide Altinöz2 Selma Şahin3
1İnönü University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Malatya, Turkey
2Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, Ankara, Turkey
3Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey
Dissolution Highlights from the 2015 AAPS Annual Meeting in Orlando

The meeting is a premier gathering of pharmaceutical scientists from around the world and works to address the needs of the attendees, including members of over 40 focus groups in nine sections, or scientific disciplines, including two focused on dissolution testing: the In Vitro Release and Dissolution Testing and QbD and Product Performance groups. Full article

Nikoletta Fotaki1 Vivian Gray2 Johannes Krämer3 Dorys Diaz4 Talia Flanagan5 Geoffrey Grove 66
1Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
2Dissolution Technologies, Hockessin, DE, USA
3PHAST, Homberg, Germany
4Pfizer, Groton, CT, USA
5Astra Zeneca, Macclesfield, UK
6Sotax, 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

In need of dissolution equipment?

Industry news

Logan Instruments Corp. Merges Its Latest Suspension System with USP 4 Testing Methods

April 6, 2016—With the success of the SUS-4000 Suspension System, Logan Instruments Corp. has advanced its design to accommodate USP 4 testing methods within the same system. In operation, the dry heat module stays in the horizontal position for suspension-cell tests. For USP 4 application, the dry heat module is moved to the vertical position, where end users can insert flow-through cells. Full article

Redefining Dissolution Qualification

Originally webcast on January 26th, 2016, to a wide audience, this webinar provides an in-depth examination of the USP Performance Verification Test and the ramifications of moving to the enhanced Mechanical Qualification (eMQ) alternative. Viewers will gain insight to the historical background and current practices regarding qualification of USP Dissolution Apparatus 1 and 2 as well as an improved model moving forward. Full article

Pion Inc. Acquires the Service Business of Vortex Sales Group

Billerica, MA, USA—April 6, 2016—Pion Inc. announced today the acquisition of the services division of Vortex Sales Group on February 2, 2016. Financial terms of the deal have not been disclosed. With the acquisition of these service contracts and service and support team members, Pion Inc. is broadening its offerings into the pharmaceutical laboratory with new instrumentation services geared toward the Analytical R&D and Quality Control laboratories. Full article

Desk Book of Pharmaceutical Dissolution Science and Applications

Question: What can you expect when expert scientists across the globe come together to publish a book on pharmaceutical dissolution science and applications? Answer: A masterpiece book—Desk Book of Pharmaceutical Dissolution Science and Applications. Full article

Hanson Research Launches New HRCare 360 Support Program

Los Angeles, CA—May 9, 2016—Hanson Research Corporation today announced the launch of HRCare 360 Support, a comprehensive program covering all dissolution and diffusion testing systems manufactured by Hanson Research. The release comes in the same year as Hanson's announcement of a three-year warranty for all instruments sold in 2016 in celebration of its 65th year in business. Full article

Distek, Inc., Celebrates 40 Years in Business

North Brunswick, NJ—March 22, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, is proud to celebrate 40 years in business. Full article

Distek, Inc., Releases Next Generation Sample Probe & Filter for Manual and Semi-Automated Sampling

North Brunswick, NJ—February 23, 2016—Distek, Inc., a leading manufacturer of pharmaceutical laboratory testing instruments, accessories, and validation services, announced today the release of its next generation sample probe and filter as the preferred product for manual and semi-automated sampling. Full article

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
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

In need of dissolution equipment?

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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