Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Patent
1997-06-16
1999-03-30
Jarvis, William R. A.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
A61K 3119
Patent
active
058890572
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/EP96/05208, filed Nov. 21, 1996.
The present invention relates to a new medical use of flurbiprofen. non-steroidal anti-inflammatory drug which also has analgesic and antipyretic activity. The flurbiprofen molecule exists in two enantiomeric forms and the term flurbiprofen as used herein is intended to embrace the individual enantiomers and mixtures thereof in any proportion including a 1:1 mixture which is herein referred to as racemic flurbiprofen. Flurbiprofen can exist in the form of pharmaceutically acceptable salts or in the form of derivatives such as esters and such salts or esters are embraced by the term "flurbiprofen" as used herein.
Flurbiprofen and its S(+) enantiomer have been proposed for treating medical conditions of the gums.
EP 137668-A (Upjohn) describes the use of flurbiprofen for preventing or inhibiting alveolar bone resorption.
EP 486561-A (Sepracor) describes the use of S(+)-flurbiprofen to treat periodontal disease and to promote bone regrowth associated with the disease. Periodontal disease is stated to include periodontitis, gingivitis and periodontosis.
Both these documents specifically describe the treatment of the gums and do not relate to any other part of the oral cavity.
The present invention relates to the use of flurbiprofen in the treatment of sore throats which comprises the administration to a patient in need of such treatment of a pharmaceutical composition in the form of a masticable or suckable solid dosage form or a spray containing a therapeutically effective amount of flurbiprofen which releases the flurbiprofen in the oral cavity so as to deliver the flurbiprofen to the surface of the sore throat.
The solid dosage form may be a lozenge which is intended to be sucked by the patient or a masticable or suckable tablet, capsule, pastille or gum, for example chewing gum. The term "lozenge" as used herein is intended to embrace all dosage forms where the product is formed by cooling a sugar-based or sugar alcohol based (eg sorbitol) molten mass containing the active material. The term "tablet" as used herein is intended to embrace unit dosage forms made from compressed powders or granules or compressed pastes. A preferred pharmaceutical composition is a lozenge prepared by cooling a heated lozenge base comprising sugar, liquid glucose, flurbiprofen and other excipients to form solid lozenges.
The therapeutically effective amount has been found to be from 5% to 40% of the normal adult dose when given by ingestion to achieve a systemic antiinflammatory and/or analgesic effect. Flurbiprofen may therefore be present in the pharmaceutical composition in an amount from 2.5 to 20 mg preferably 5 to 12.5 mg. Where a pharmaceutically acceptable salt of flurbiprofen is used, the amount of the salt used should be such as to provide the desired amount of flurbiprofen. Suitable salts include the alkali metal salts eg the sodium salt or amino acid salts eg the lysine, arginine or meglumine salts of flurbiprofen.
Flurbiprofen would be expected, in common with other non-steroidal anti-inflammatory agents, to cause an unpleasant burning sensation at the back of the mouth when retained in the mouth. This would clearly be unacceptable to the patient being treated. The present applicants have surprisingly found that an unacceptable burning sensation is not experienced when the present invention is used to treat a sore throat but that the patient does receive relief of the symptoms of the sore throat.
Solid dosage forms may be prepared by methods which are well known in the art for the production of lozenges, tablets, capsules or chewing gums and may contain other ingredients known in such dosage forms such as acidity regulators, opacifiers, stabilising agents, buffering agents, flavourings, sweeteners, colouring agents, buffering agents, flavourings, sweeteners, colouring agents and preservatives. For example, the preferred solid formulations of the present invention may be prepared as lozenges by heating the lozenge base (eg a mixture of sugar and liqui
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Barrett David Michael
Smith Carl Simon
Thurgood David Michael
Jarvis William R. A.
The Boots Company PLC
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