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Hot-melt extrusion
In-Depth Study into Polymeric Materials in Low-Density Gastroretentive Formulations
The extensive use of oral dosage forms for the treatment of diseases may be linked to deficient pharmacokinetic properties. In some cases the drug is barely soluble; in others, the rapid transit of the formulation through the gastrointestinal tract (GIT) makes it dicult to achieve therapeutic levels…
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Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion
To avoid any type of cross-contamination, residue-free production equipment is of utmost importance in the pharmaceutical industry. The equipment cleaning for continuous processes such as hot melt extrusion (HME), which has recently gained popularity in pharmaceutical applications, necessitates…
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Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to…
This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts,…
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The design and development of high drug loading amorphous solid dispersion for hot-melt extrusion…
Amorphous solid dispersion (ASD) is a formulation strategy extensively used to enhance the bioavailability of poorly water soluble drugs. Despite this, they are limited by various factors such as limited drug loading, poor stability, drug-excipient miscibility and the choice of process platforms. In…
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Solving the Insoluble with AFFINISOL™ HPMC
AFFINISOL™ hydroxypropyl methylcellulose (HPMC) is a water-soluble cellulosic polymer that can help optimize solubility enhancement by maintaining stable solid dispersions and inhibiting API crystallization.
More sophisticated drug discovery techniques have led to pipeline compounds that require…
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Application and Functional Characterization of Kollicoat Smartseal 30D as a Solid Dispersion Carrier…
Many new chemical entities that are getting developed are poorly aqueous soluble and have low bioavailability. Out of many methods available for improving solubility, the solid dispersion by melt extrusion (ME) and spray drying (SP) is scalable and industrially applicable methods.
Objective: The…
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Hot melt extruded zein for controlled delivery of diclofenac sodium: Effect of drug loading and…
This study evaluates the potential use of zein as an excipient in hot-melt extrusion for controlled delivery of diclofenac sodium (DS). Mixtures of zein, polyethylene glycol and drug were hot melt extruded and cut into 2 mm extrudates. Extrudates were characterised using differential scanning…
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Characterization of ternary amorphous solid dispersion containing hypromellose phthalate and…
Hot melt extrusion is a promising technology for producing amorphous solid dispersions, however, there is a risk of thermal degradation or residual crystallinity formation. This caveat may be addressed by optimizing formulations and manufacturing conditions. The aim of our study was to explore…
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Influence of Carbamazepine Dihydrate on the Preparation of Amorphous Solid Dispersions by Hot Melt…
Amorphous solid dispersions (ASDs) are commonly used in the pharmaceutical industry to improve the dissolution and bioavailability of poorly water-soluble drugs. Hot melt extrusion (HME) has been employed to prepare ASD based products. However, due to the narrow processing window of HME, ASDs are…
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The manufacture of fixed dose combination products using advanced pharmaceutical techniques for the…
Thesis by Jeremiah Kelleher, School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, The University of Dublin
The thesis has focused on the use of continuous manufacturing techniques to produce fixed dose combination (FDC) products for the treatment of type II diabetes mellitus…
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