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Solid Dosage Forms containing Dutasteride self-emulsifying lipidic Formulations

IP.com Disclosure Number: IPCOM000173742D
Publication Date: 2008-Aug-22
Document File: 2 page(s) / 7K

Publishing Venue

The IP.com Prior Art Database

Abstract

An elegant and easy way to combine the excellent drug delivery of Dutasteride SELF systems with the advantage of a Dutasteride tablet formulation in terms of easy manufacture and longer shelf life was developed in orderto overcome the low solubility of Dutasteride. A preferable way to process the liquid and oily SELF systems was discovered by adsorbing the oily liquids onto a neutral carrier (e.g. neutral silicate) by a mixing process, for instance in a conventional high shear mixer. The resulting powder mixture was filled into capsules or formulated with additional excipients and compressed into tablets. The analytical characteristics, and in particular, the dissolution rates of these formulations was found to be excellent and comparable to the dissolution rate of Avodart® capsules.

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Solid Dosage Forms containing Dutasteride self-emulsifying lipidic
Formulations

Dutasteride, sold under the tradename Avodart®, is used in the
treatment of prostate gland enlargement (benigni prostate
hyperplasia, BPH). The drug is administered as soft gelatin
capsule, containing the API (0.5mg) dissolved in a mixture of
mono- diglycerides of caprylic/capric acid and butylated
hydroxytoluene, as described in the patent applications
EP 1 005 346 and EP 1 007 010.

To overcome the very low solubility of Dutasteride and other low
soluble drugs several SELF systems (self emulsifying) with
increased dissolution characteristics have been described in the
literature (e.g. "Approaches for the development of solid and
semi-solid lipid-based formulations", in Advanced Drug Delivery
Reviews 60 (2008), p. 734 - 746). Two types of SELF systems are
well decribed, self emulsifying delivery systems (SEDDS) and self
micro-emulsifying drug delivery systems (SMEDDS). Both systems
lead to dosage forms characterized by improved drug delivery
properties. Because of the oily or semi-solid state of these SELF
systems, they have to be filled into capsules, such as soft or
hard gelatin capsules or capsules made of other materials, e.g.
starch or HPMC.

An elegant and easy way to combine the excellent drug delivery of
SELF systems with the advantage of a tablet formulation in terms
of easy manufacture and longer shelf life is described (e.g. in
"Pharmaceutical Technology Europe" April...