Research on Hot Melt Extrusion Processing for Drug Formulation and Drug Delivery

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: 20 July 2024 | Viewed by 2092

Special Issue Editors


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Guest Editor
Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, USA
Interests: hot-melt extrusion; colon-specific drug delivery; fast-dissolving tablets; formulation and pharmacokinetics

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Guest Editor
Distinguished Professor, Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, MS 38677, USA
Interests: hot-melt extrusion (HME) for enhancing solubility and bioavailability of poorly soluble drugs; pharmaceutical novel dosage forms and devices; HME and fused deposition modeling for complex patient centric delivery to pediatric, geriatric and special needs patients; polymeric drug delivery design and stabilization; formulation and process development for natural products; antifungal/antibacterial agents; research on several drug delivery areas including oral, transdermal/trans-nail, nose-to-brain, and transcorneal delivery
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Guest Editor
Department of Pharmaceutical Technology (Formulations), National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam 781101, India
Interests: hot-melt extrusion; melt granulation; lipid-based DDS; topical formulations; solid dispersions

Special Issue Information

Dear Colleagues,

The pharmaceutical industry has shown increased interest in hot-melt extrusion (HME) technology, as evidenced by a rise in patents and publications. HME is becoming popular in pharmaceutical applications to develop various drug delivery systems due to its eco-friendly approach to continuous manufacturing without solvents. HME has proven very efficient in enhancing the solubility and dissolution of poorly water-soluble drugs via the development of amorphous solid dispersions. During the process, the active pharmaceutical ingredient is mixed at a molecular level with thermoplastic binders and/or polymers while passing through high-temperature counter-rotating or corotating screw elements. This molecular mixing process transforms the active pharmaceutical ingredient into an amorphous form and improves the dissolution rate. Additionally, it is an essential tool for producing innovative pharmaceutical products. HME is being investigated as an alternative technology for preparing multicomponent systems such as co-crystals and co-amorphous techniques. Twin-screw granulation has drawn increased attention in preparing granules via twin-screw melt or dry granulation.

We welcome submissions from researchers exploring hot-melt extrusion processing for drug formulation and delivery.

The purpose of this Special Issue, "Research on Hot Melt Extrusion Processing for Drug Formulation and Drug Delivery" is to gather original research articles and reviews on the formulation and in-vitro/in-vivo characterization of various drug delivery systems such as amorphous solid dispersions, co-crystals, SEEDS, and any other fast-dissolving systems using hot-melt extrusion. It also works using modified-release systems such as controlled-release tablets/implants/pellets, colon-specific delivery, gastroretentive systems, and mucoadhesive systems via the application of hot-melt extrusion. Works aimed at increasing the application of HME knowledge to improve dissolution rates or bioavailability in order to enhance overall therapeutic efficacy are welcome.

We look forward to receiving your contributions.

Dr. Sateesh Kumar Vemula
Prof. Dr. Michael A. Repka
Dr. Naveen Chella
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • hot-melt extrusion (HME)
  • pharmaceutical industry
  • twin-screw granulation
  • continuous manufacturing
  • drug delivery
  • solubility and dissolution
  • amorphous form
  • bioavailability
  • formulation and development
  • in-vitro/in-vivo characterization

Published Papers (1 paper)

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Research

25 pages, 4065 KiB  
Article
Material-Sparing Feasibility Screening for Hot Melt Extrusion
by Amanda Pluntze, Scott Beecher, Maria Anderson, Dillon Wright and Deanna Mudie
Pharmaceutics 2024, 16(1), 76; https://doi.org/10.3390/pharmaceutics16010076 - 05 Jan 2024
Viewed by 1332
Abstract
Hot melt extrusion (HME) offers a high-throughput process to manufacture amorphous solid dispersions. A variety of experimental and model-based approaches exist to predict API solubility in polymer melts, but these methods are typically aimed at determining the thermodynamic solubility and do not take [...] Read more.
Hot melt extrusion (HME) offers a high-throughput process to manufacture amorphous solid dispersions. A variety of experimental and model-based approaches exist to predict API solubility in polymer melts, but these methods are typically aimed at determining the thermodynamic solubility and do not take into account kinetics of dissolution or the associated degradation of the API during thermal processing, both of which are critical considerations in generating a successful amorphous solid dispersion by HME. This work aims to develop a material-sparing approach for screening manufacturability of a given pharmaceutical API by HME using physically relevant time, temperature, and shear. Piroxicam, ritonavir, and phenytoin were used as model APIs with PVP VA64 as the dispersion polymer. We present a screening flowchart, aided by a simple custom device, that allows rapid formulation screening to predict both achievable API loadings and expected degradation from an HME process. This method has good correlation to processing with a micro compounder, a common HME screening industry standard, but only requires 200 mg of API or less. Full article
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