APRs Patented Diclofenac 25 mg OTC Immediate Release tablets launched in New Zealand by Douglas Pharmaceuticals Ltd.

Diclofenac Potassium 25 mg film-coated tablets, recently approved by MEDSAFE in New Zealand as OTC medication, have been launched in New Zealand by Douglas Pharmaceuticals Ltd., under the license of APR.

(PRWEB) September 25, 2004 -- Diclofenac Potassium 25 mg film-coated tablets, recently approved by MEDSAFE in New Zealand as OTC medication, have been launched in New Zealand by Douglas Pharmaceuticals Ltd., under the license of APR.

Diclofenac Potassium 25 mg film-coated tablets are an immediate release formulation which has been patented and developed by APR Applied Pharma Research SA, the Swiss based R&D Company.

On October 13 2003, MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority) granted the authorization to Douglas Pharmaceuticals Ltd, New Zealand, to market APRs Diclofenac Potassium film coated, immediate release tablets under the trade name Oraflam®.

The product has been officially launched in July this year
Oraflam® will be sold in packs of 20 and 30 blistered tablets as a Pharmacist Medicine (they may be sold without a prescription, but the sale must be made by a registered pharmacist, in a pharmacy, and details of the sale must be recorded).

Oraflam® will be indicated for the relief of acute painful and inflammatory conditions with the following posology: adults, initially 2 tablets, then if necessary 1 or 2 tablets every 8 hours; children over 14 years of age, 1 tablet 3 times daily; not exceeding 6 tablets daily.

APR Diclofenac Potassium 25 mg film-coated tablets formulation has many advantages over already marketed immediate release formulations:
·   immediate release profile, equivalent to intramuscular injection
·   faster absorption: Cmax in 21 min compared to 50 min of Cataflam®
·   very quick onset of action
·   regularity of absorption (reduced standard deviation)

Total market of OTC diclofenac pain killer preparation in New Zealand is about USD $1 Mill. per year; Oraflam®, which is an already existing brand from Douglas, is expected to reach USD $300,000 in sales per year and to reach a 30% market share in 2 years from launch.

The innovation of this formulation allows brand defence against COX-2. The easy to transfer know-how and the cost competitive manufacturing process (dry mixing for direct compression) are two additional plus of APRs formulation.

Further than in New Zealand where the product has already been launched, Diclofenac Potassium 25 mg film-coated tablets have already been licensed-out by APR in several other countries in Europe and outside.

APR Applied Pharma Research s.a. is a privately owned, pure R&D company with registered offices in Switzerland. It is focused in the research & development of innovative and patented drug delivery systems as well as innovative pharmaceutical products primarily for oral and topical administration. APR products and technologies are licensed to third parties for distribution and marketing activities. R&D activities are carried out directly or under contract. APR has signed licensing agreements with pharmaceutical companies worldwide and its sales are almost totally achieved abroad.

Interview Contact: Paolo Galfetti, Licensing Director, Telephone: +41.91.6957020 Email: paolo.galfetti@apr.ch Website: www.apr.ch
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