Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1996-08-26
1999-08-17
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424 111, 424470, A61K 914
Patent
active
059391006
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention concerns a composition for drug delivery and a method for the manufacturing thereof. Specifically the invention concerns a composition in which a drug is bound to starch microspheres. The composition according to the invention is of particular interest for nasal delivery. The composition is primarily intended as an aid in nicotine replacement therapy.
OBJECTIVES OF THE INVENTION
A primary objective of the invention is to provide for a new and inventive pharmaceutical composition for nasal, oral, buccal or pulmonary administration of nicotine. The objective is achieved with a powdery composition comprising nicotine incorporated in degradable starch microspheres.
A further objective of the invention is to provide for a method of incorporating nicotine into starch microspheres.
A still further objective of the invention is to provide for a method for diminishing the desire of a person to use tobacco which comprises administering to that person a composition comprising nicotine incorporated into degradable starch microspheres.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 illustrates the mean nicotine concentration in the plasma of rats as a function of time after nasal absorption of nicotine from the nicotine-Spherex.RTM. microspheres.
FIG. 2 shows the plasma nicotine values as a function of time in animals after i.v. administration of nicotine.
BACKGROUND
In the U.S. Surgeon General's 1979 report on Smoking and Health, it was estimated that in the U.S. alone about 350,000 deaths are caused each year by diseases related to cigarette smoking. In fact, excessive smoking is now recognized as one of the major health problems throughout the world.
The most advantageous thing a heavy smoker can do is, therefore, to reduce or preferably even stop smoking completely. Experience shows, however, that most smokers find this extremely difficult. It is generally accepted that this difficulty results from the fact that heavy smokers are dependent on nicotine, which is considered to be one of the risk factors in tobacco smoke. The most important risk factors, however, are substances which are formed during the combustion of tobacco, such as carbon monoxide, tar products, aldehydes, and hydrocyanic acid.
One way to reduce smoking would, of course, be to provide nicotine in a form or manner other than by smoking. There are available tobacco products which can be used for this purpose, such as chewing tobacco and snuff, which latter material can be administered both via nasal and oral routes. Tobacco products of this type are, however, not without harmful effects, such as cancer, and are not well accepted socially. One already existing product, which fulfils the above-mentioned objective of providing nicotine in a less harmful and more socially-acceptable manner, is a nicotine chewing gum. Nicotine-containing chewing gums are not new. U.S. Pat. Nos. 865,026 and 940,521 are representative of ancient efforts along these lines. More recently, however, U.S. Pat. Nos. 3,877,468, 3,901,248 and 3,845,217 have appeared, and the products of the latter of these three patents are now being marketed on an international scale. These products combine a nicotine-containing cation exchange resin complex in gum base, preferably together with a buffering agent which maintains the pH of the saliva above its normal physiological pH.
It seems particularly difficult to find other smoking substitutes equivalent to or as effective as the chewing gum substitutes just mentioned, and the aerosol compositions of the Gildermeister or Smith British Pat. Nos. 1,528,391 or 2,030,862, adapted to be sprayed into the mouth of the user, are hardly an answer to the problem and in actuality appear to be merely a particular extension of a suggestion made as early as 1967 (A. Herxheimer et al, Lancet 1967, II 754-5).
Unilever in German Offenlegungsschrift No 2,313,996, published Oct. 10, 1974, describes certain water-soluble readily-absorbed snuff powders and a process for their manufacture, but these involve only extrac
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J. Pharm. Pharmacol., vol. 45, Apr. 1993, B.C. Thanoo et al., "Controlled Release of Oral Drugs from Cross-linked Polyvinyl Alcohol Microspheres".
Albrechtsen Sten
Hansen Jens
Mollgaard Birgitte
Orup-Jacobsen Lene
Benston, Jr. William E.
Page Thurman K.
Pharmacia and UpJohn AB
Villacorta Gilberto M.
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