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Lactose
Oral Solid Dose – Direct Comparison of Pharmacel® 101 and Pharmacel® 102
High-quality excipients
Oral Solid Dose
A comprehensive range of highly consistent excipients for OSD formulations, including a full range of lactose (milled monohydrate, sieved monohydrate, micronized, anhydrous, spray dried, and granulated), cellulosics and starches portfolio comprising of…
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Comprehensive Review of Modern Techniques of Granulation in Pharmaceutical Solid Dosage Forms
ABSTRACT
This comprehensive review explores modern granulation techniques in pharmaceutical dosage forms along with conventional methods, focusing on dry granulation and wet granulation. Dry granulation techniques, including slugging, roller compaction, and pneumatic dry granulation, are…
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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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Impact of Co-Processing on the Structural Evolution of Lactose and MCC, Investigated by Laboratory…
Introduction
Within the last decades a new subgroup of diluents, so called Co-processed Excipients (CPE), found its way into pharmaceutical practice . After a seemingly endless discussion about their definition, state, and boundaries to a simple physical admixture (PAM), CPE have been defined as a…
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The effect of glidant on the tabletting behavior of common pharmaceutical excipients
Abstract
Glidant used for the purpose of powder flowability enhancement is well known within the pharmaceutical industry to improve tablet manufacturing. Despite the widespread use of glidant for this purpose, the effect of glidant on the effect of tableting behavior is not well studied. To address…
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Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal…
The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may…
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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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Development of novel portable NIR spectroscopy process analytical technology (PAT) tool for…
The aim of this research was to develop a process analytical technology (PAT) tool for monitoring the transformation process of the active ingredient ibuprofen into the fast-dissolving salt ibuprofen sodium during the wet granulation process. Two near-infrared (NIR) spectrophotometers, namely…
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Fine excipient materials in carrier-based dry powder inhalation formulations: The interplay of…
Abstract
The contributions of fine excipient materials to drug dispersibility from carrier-based dry powder inhalation (DPI) formulations are well acknowledged, although they are not fully elucidated. To improve the understanding of these contributions, we studied the influences of the particle…
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