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Crospovidone
Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration…
Abstract
Forty-eight (48) drug products (DPs) containing amorphous solid dispersions (ASDs) have been approved by the U.S. Food and Drug Administration in the 12-year period between 2012 and 2023. These DPs comprise 36 unique amorphous drugs. Ten (10) therapeutic categories are represented, with…
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Evaluation of binders in twin-screw wet granulation – Optimization of tabletability
Abstract
The influence of hydroxypropyl cellulose type (HPC-SSL SFP, HPC-SSL), concentration (2 %, 3.5 %, 5 %) and filler (lactose, calcium hydrogen phosphate (DCP)/microcrystalline cellulose (MCC)) on twin-screw wet granulation and subsequent tableting was studied. The aim was to identify the…
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Update: Risk Mitigation of Nitrosamines Formation in Drug Products: Role of Excipients
1. Introduction
The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical industry and health authorities. In June 2018, the FDA was notified of the presence of N-nitrosodimethylamine (NDMA), an impurity found in valsartan, an…
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Selection of lubricant type and concentration for orodispersible tablets
Abstract
Lubricants are essential for most tablet formulations as they assist powder flow, prevent adhesion to tableting tools and facilitate tablet ejection. Magnesium stearate (MgSt) is an effective lubricant but may compromise tablet strength and disintegratability. In the design of…
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Kollidon® 90 Evo – A highly effective water soluble binder with low impurity profile
Join the evolution of the BASF PVP portfolio! Kollidon® 90 Evo combines outstanding purity and innovative packaging.
Kollidon® 90 Evo is a highly effective binder with exceptional purity
Very low impurity profile, e.g., 2-pyrrolidone, aldehydes and hydrazine
Broad range of applications…
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Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet
An industrial case study of attempting to comply with EU regulation 2022/63
Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the…
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Advancing oral drug delivery: The science of fast dissolving tablets (FDTs)
The field of oral drug delivery has witnessed significant advancements, with a focus on developing innovative formulations to address challenges associated with traditional dosage forms, especially for patients with difficulties in swallowing. Fast Dissolving Tablets (FDTs) have emerged as a…
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A Comprehensive Review of Disintegrants: Backbone of disintegration
Abstract
Strong attractive bonding forces works among the particles of solid dosage forms such as mechanical, solid and intermolecular and bioavailability of solid dosage form is preferentially dependent on in vivo disintegration then dissolution. This review is focused for disintegrating agents,…
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Development of α-Cyclodextrin-Based Orally Disintegrating Tablets for 4-Phenylbutyrate
Despite major improvements brought about by the introduction of taste-masked formulations of 4-phenylbutyrate (PB), poor compliance remains a significant drawback to treatment for some pediatric and dysphagic patients with urea cycle disorders (UCDs). This study reports on the development of a…
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Solidifying Fenofibrate Nanocrystal Suspension: A Scalable Approach via Granulation Method
The pharmaceutical industry has highlighted particle-size reduction via preparing aqueous suspensions containing nano- or submicron drug particles. Owing to the risk of agglomeration and complications during the manufacturing of solid dosage forms, the problems associated with the solidification of…
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