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DFE Pharma
The challenge of downstream processing of spray dried amorphous solid dispersions into minitablets…
Poorly water-soluble drugs present a significant challenge in the development of oral solid dosage forms (OSDs). In formulation development the appropriate use of excipients to adjust solubility, and the choice of manufacturing method and pharmaceutical processes to obtain a dosage form to meet the…
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Implementation of near-infrared spectroscopy and convolutional neural networks for predicting…
Monitoring the particle size distribution (PSD) is crucial for controlling product quality during fluidized bed granulation. This paper proposed a rapid analytical method that quantifies the D10, D50, and D90 values using a Convolutional Block Attention Module-Convolutional Neural Network (CBAM-CNN)…
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Studying the API Distribution of Controlled Release Formulations Produced via Continuous Twin-Screw…
Abstract
Hydroxypropyl methylcellulose (HPMC) is a preferred hydrophilic matrix former for controlled release formulations produced through continuous twin-screw wet granulation. However, a non-homogeneous API distribution over sieve fractions with underdosing in the fines fraction (<150 µm) was…
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Development of a New Bioequivalent Omeprazole Product
Abstract
Background and Objectives: The enteric form of omeprazole is one of the most commonly prescribed medications. Similarly to Europe, Kazakhstan relies on the localization of pharmaceutical drug production as one of its primary strategies to ensure that its population has access to affordable…
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The impact of diluents on the compaction, dissolution, and physical stability of amorphous solid…
Abstract
Amorphous solid dispersion (ASD) is an effective approach for enhancing the solubility, dissolution, and bioavailability of poorly water-soluble drugs. However, these metastable forms can transform into more thermodynamically stable, less soluble crystalline forms. Despite this…
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Novel inhalable powder formulation of pirfenidone with sustained release properties to improve…
Abstract
The aim of this study was to develop a new respirable powder (RP) formulation of pirfenidone (PFD) with sustained release properties to ameliorate the pharmacokinetic drawbacks of the previously-developed PFD-RP on rapid elimination from the lung after insufflation. Based on screenings…
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Impact of dry coating lactose as a brittle excipient on multi-component blend processability
Abstract
Previous work demonstrated the benefits of dry coating fine-grade microcrystalline cellulose (MCC) for enabling direct compression (DC), a favored tablet manufacturing method, due to enhanced flowability while retaining good compactability of placebo and binary blends of cohesive APIs.…
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Sample Size Requirements of a Pharmaceutical Material Library: A Case in Predicting Direct…
The material library is an emerging, new data-driven approach for developing pharmaceutical process models. How many materials or samples should be involved in a particular application scenario is unclear, and the impact of sample size on process modeling is worth discussing. In this work, the…
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HME as Advanced Approach for Development of Solid Self Emulsifying Drug Delivery System
The pharmaceutical industry is paying more and more attention to hot-melt extrusion (HME), but this technology's promise for creating solid self-emulsifying drug delivery systems (S-SMEDDS) has not yet been fully realized. The numerous published publications over the past five years show that hot…
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Formulation and Preparation of Losartan-Potassium-Loaded Controlled-Release Matrices Using Ethocel…
In the current study, matrices of losartan potassium were formulated with two different polymers (Ethocel 10 premium and Ethocel 10FP premium), along with a filler and a lubricant, at different drug-to-polymer w/w ratios (10:3, 10:4, and 10:5). The matrices were tested by the direct compression…
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