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  • Title: Gelucire 44/14 based immediate release formulations for poorly water-soluble drugs.
    Author: da Fonseca Antunes AB, De Geest BG, Vervaet C, Remon JP.
    Journal: Drug Dev Ind Pharm; 2013 May; 39(5):791-8. PubMed ID: 22871141.
    Abstract:
    Here, we aim to evaluate Gelucire 44/14 as non-ionic surface-active excipient to produce immediate-release solid dosage forms for poorly water-soluble drugs. Gelucires are polyethylene glycol (PEG) glycerides composed of mono-, di- and triglycerides and mono- and diesters of PEG. They are inert semi-solid waxy amphiphilic excipients with surface-active properties that spontaneously form a fine dispersion or emulsion upon contact with water. Monolithic Gelucire 44/14 structures are prone to prolonged erosion times, thereby slowing down drug dissolution. To overcome this issue, we combine either granulation or spray-drying, followed by compression into tablets, with an optimized composition of disintegration promoting agents. This formulation strategy allows obtaining nearly 100% drug release within 10 min dissolution time.
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