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Solvent-free melting techniques for the preparation of lipid-based solid oral formulations.

Pharmaceutical research (2015-03-20)
Karin Becker, Sharareh Salar-Behzadi, Andreas Zimmer
ABSTRACT

Lipid excipients are applied for numerous purposes such as taste masking, controlled release, improvement of swallowability and moisture protection. Several melting techniques have evolved in the last decades. Common examples are melt coating, melt granulation and melt extrusion. The required equipment ranges from ordinary glass beakers for lab scale up to large machines such as fluid bed coaters, spray dryers or extruders. This allows for upscaling to pilot or production scale. Solvent free melt processing provides a cost-effective, time-saving and eco-friendly method for the food and pharmaceutical industries. This review intends to give a critical overview of the published literature on experiences, formulations and challenges and to show possibilities for future developments in this promising field. Moreover, it should serve as a guide for selecting the best excipients and manufacturing techniques for the development of a product with specific properties using solvent free melt processing.

MATERIALS
Product Number
Brand
Product Description

Supelco
Hydrogen chloride – ethanol solution, ~1.25 M HCl, for GC derivatization, LiChropur
Supelco
Riboflavin, Pharmaceutical Secondary Standard; Certified Reference Material
Lansoprazole, European Pharmacopoeia (EP) Reference Standard
Supelco
Hydrogen chloride – 2-propanol solution, ~1.25 M HCl (T), for GC derivatization, LiChropur
Lansoprazole for peak identification, European Pharmacopoeia (EP) Reference Standard
Theophylline, European Pharmacopoeia (EP) Reference Standard
Paracetamol, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Hydrochloric acid solution, 32 wt. % in H2O, FCC
Ibuprofen for peak identification, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Hydrochloric acid, 36.5-38.0%, BioReagent, for molecular biology
Sigma-Aldrich
Sodium bicarbonate, powder, BioReagent, for molecular biology, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Griseofulvin, from Penicillium griseofulvum, 97.0-102.0%
Sigma-Aldrich
Ibuprofen, meets USP testing specifications
Sigma-Aldrich
Ibuprofen, ≥98% (GC)
Sigma-Aldrich
Hydrogen chloride solution, 3 M in cyclopentyl methyl ether (CPME)
Supelco
Ibuprofen, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Theophylline, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
(−)-Riboflavin, BioReagent, suitable for cell culture, suitable for insect cell culture, ≥98%
Sigma-Aldrich
(−)-Riboflavin, from Eremothecium ashbyii, ≥98%
Sigma-Aldrich
Lansoprazole, ≥98% (TLC), powder
Sigma-Aldrich
Theophylline, anhydrous, ≥99%, powder
Sigma-Aldrich
Sodium bicarbonate, Hybri-Max, powder, suitable for hybridoma, ≥99.5%
Sigma-Aldrich
(−)-Riboflavin, meets USP testing specifications
Sigma-Aldrich
Sodium bicarbonate, BioXtra, 99.5-100.5%
Sigma-Aldrich
Hydrochloric acid solution, 1.0 N, BioReagent, suitable for cell culture
Supelco
Hydrochloric acid solution, volumetric, 0.1 M HCl (0.1N), endotoxin free
Sigma-Aldrich
Sodium bicarbonate, tested according to Ph. Eur.
Sigma-Aldrich
Hydrochloric acid solution, ~6 M in H2O, for amino acid analysis
Supelco
Ibuprofen
Sigma-Aldrich
Hydrogen chloride solution, 2.0 M in diethyl ether