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December 11, 2020

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Comprehensive Analysis into Disintegration Mechanisms: How Reliable are Textbook Recommendations?

When formulating a tablet, the solubility of the tablet matrix is often used as the sole criteria for disintegrant selection. Most formulators tend to select swelling-type disintegrants for insoluble matrices and wicking-type disintegrants for soluble matrices.

This executive summary presents an in-depth analysis of the effects of disintegration mechanisms, pH of test media, matrix plasticity, tablet hydrophobicity, and storage effects on the disintegration behavior. In addition, the interaction of disintegrants in the tablet surface with environmental humidity is taken into consideration as an additional element for rational excipient selection.

	Industry News

FDA Authorizes First Direct-to-Consumer COVID-19 Test System
The FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 ... read more »

Torrent Recalls Anagrelide Capsules, USP Due to Dissolution Test Failure
Torrent is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to ... read more »

FDA Approves First Drug to Treat Rare Metabolic Disorder
The FDA approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1, a rare ... read more »

PhoenixMD Announces First Patient Dosed in Triple Negative Breast Cancer Trial
PhoenixMD announced the first patient has been dosed in their Phase 1b clinical trial of PMD-026. read more »

Oramed Initiates Phase 3 Trial of Oral Insulin
Oramed has screened the first patients in its global Phase 3 trials of its oral insulin capsule ORMD... read more »

FDA Grants Accelerated Approval to naxitamab for Neuroblastoma in Bone or Bone Marrow
The FDA granted accelerated approval to naxitamab in combination with GM-CSF for pediatric patients ... read more »

	QC Corner

A Roadmap for Implementing QRM Principles in Drug Substance Manufacturing
The ICH Q7 good manufacturing practice (GMP) guidance for active pharmaceutical ingredients (API) ... read more »

The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to ... read more »

	Infographic

Excipients Matter: Harness the Power of Excipients
Excipients Matter: Harness the Power of Excipients
Traditionally used as bulking agents, excipients play an increasingly active role in fine-tuning the properties of active pharmaceutical ingredients (... read more »

	Featured Articles

Harnessing Synthetic Lipids for Drug Development: Strategies for Success Lipids are gaining enhanced momentum due to their vital role in the field of ribonucleic acid (RNA) therapeutics and vaccine development for diseases ... read more »

Process Analytical Technology and Digital Biomanufacturing of Monoclonal Antibodies Biomanufacturing is moving toward digital manufacturing with increased application of Process Analytical Technology (PAT) and continuous manufacturing... read more »

	Featured Video

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... watch »

On-Demand Webinar: A 360 Overview of Data Integrity in Life Sciences
In this webinar, you’ll learn the most common pitfalls and challenges Life Sciences companies are facing when improving their data integrity, how to ... watch »

	Featured Products

MAS-100 ISO NT Microbial Air Sampler
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Gemini HPLC Columns
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	Featured Whitepaper

New Data to Support Activation Test for pyrogen detection Detect both endotoxin and non-endotoxin pyrogens in a single in vitro assay
Wondering how suitable a cell line-based Monocyte Activation Test is for detecting pyrogens? read more »

R&D to Product: How to reduce costly scale-up problems
When scaling a new drug formuation. read more »

	Events

Injectable Drug Delivery 2021
Kensington, London – 05/12/2021
Innovations in formulation and device design for enhanced subcutaneous delivery SMi Group is pleased to announce the third annual Injectable Drug ... event details »

Pre-Filled Syringes West Coast 2021
Virtual – 06/14/2021
Assessing Device Development and Regulation for Advanced Innovation SMi is proud to present the 5th Annual Pre-Filled Syringes West Coast ... event details »

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