Abstract
A Novel Solvent System to Prepare Pellets of Active Pharmaceutical Ingredients Having Tacky Wet-Mass Forming Propensity By Extrusion Spheronization Technique
Highlights
Itopride hydrochloride (IH) is a prokinetic benzamide derivative that has been widely used for the treatment of functional dyspepsia and other gastrointestinal conditions [1]
IH has propensity to form a tacky wet-mass when comes in contact with water, specially in presence of some commonly used pharmaceutical excipients such as hydroxypropyl methyl cellulose
We explored a range of non-conventional solvent system prepared using combination of purified water with glycerol, polyethylene glycol (PEG 400), poloxamer and sodium lauryl sulphate in various different concentrations
Summary
Itopride hydrochloride (IH) is a prokinetic benzamide derivative that has been widely used for the treatment of functional dyspepsia and other gastrointestinal conditions [1]. It is a combined D2 receptor antagonist and acetylcholinesterase inhibitor. Neutral cores are coated with API and excipient followed by a functional coating [5]. The layering technique is preferred when the amount of API is low in formulation (low dose APIs). It has been well acknowledged that water, as a solvent, has potential to produce discrete and spherical pellets of a variety of pharmaceutical APIs. Nov Appro Drug Des Dev 3(5): NAPDD.MS.ID.555625 (2018)
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