Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2001-05-31
2002-05-21
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Reexamination Certificate
active
06391284
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a process based on the removal of alcohol from alcoholic/aqueous pharmaceutical preparations, and more particularly to a nonalcoholic pharmaceutical composition, formulated in the presence of alcohol, obtained by performing the process.
BACKGROUND OF THE INVENTION
Pharmaceutical preparations typically need a vehicle which allows for the dissolution of components necessary to produce the final product. The vehicle is commonly ethyl alcohol, which is used to provide a fully dissolved and chemically and physically stable pharmaceutical composition. Particularly for example, in mouthwashes, oral rinses, and other pharmaceutical preparation used in maintaining oral hygiene, the use of alcohol is believed to be essential for solubilization of the components of the formulation. Without the ability to completely dissolve active compounds within a preparation and have these compounds remain both chemically and physically stable in the preparation, the resulting pharmaceutical composition could be therapeutically ineffective, unstable and unclear and result in inactivity against tooth decay, plaque, gum disease and oral ulcers.
Most conventional pharmaceutical compositions including mouthwashes and oral rinses contain a significantly high level of ethyl alcohol in their compositions. Typically, the level of ethyl alcohol ranges from 10% to 30% by volume, based on the total mouthwash volume. Generally, alcohol is used in pharmaceutical formulations not only for its disinfecting function, but also to assist in the dissolution of other compounds in the formulation, and to maintain a role as an effective preservative during storage.
Understandably, however the uses of alcohol in consumer health products has become undesirable, and imposes a number of inherent limitations and detrimental side effects upon use. Notwithstanding, the potential medical and health problems of which alcohol's inclusion in a wide variety of pharmaceutical compositions and orally ingested products imposes, the presence of alcohol also presents potential social implications for some users. Typically, the ingestion of alcohol even in small doses is likely to cause drowsiness, and should be avoided when operating heavy machinery and automobiles. Additionally, alcohol and its abuse is a recognized major social problem. Abuse of alcohol in all its forms is considered an illness, and contact with non-beverage alcohol can trigger setbacks in recovering alcoholics. Therefore, a substantially nonalcoholic aqueous pharmaceutical preparation used in maintaining oral hygiene is desirable, inter alia, for the safety of those individuals who cannot or should not use an oral aqueous pharmaceutical composition containing alcohol.
Furthermore, ethyl alcohol containing pharmaceutical compositions including oral rinses are generally not recommended for use by children. Many parents are concerned about the alcohol content, while many children reject the alcohol bite and astringency characteristics of such products. Moreover, the use of alcohol in many pharmaceutical compositions including orally ingested products results in gingival, periodontal and soft tissue irritation. At such time, alcoholic rinses cause even greater pain and are often replaced by rinsing with water, without receiving the benefits of the pharmaceutically active components. Even the substitution of ethyl alcohol with other solubilizing alcohols such as methanol or isopropyl alcohol in pharmaceutical preparations that have some potential for ingestion, have been found to be even more objectionable because they have local and systemic toxicities.
Over the years different strategies have been employed to achieve a pharmaceutical composition that effectively maintains its chemical and physical stability, yet does not contain alcohol. In cases of oral hygiene compositions, the art has been unable to successfully produce an oral composition by a simple and economical process that results in an alcohol free preparation that still effectively eliminates bacteria. Some antimicrobial compositions contain a reduced amount of alcohol in the presence of flavoring oils and surfactants, while others have incorporated flavoring oils and antibacterial agents in a dry formulation which is dissolved in water just prior to use, requiring preparation by the user.
In summary, several approaches have been explored to achieve a nonalcoholic composition, however none have been able to achieve an improved process that successfully removes alcohol from the composition while still maintaining stability and effectiveness. The art, therefore, lacks a stable and clear substantially nonalcoholic, aqueous pharmaceutical composition, which is physically and chemically effective. It is therefore an object of the present invention to provide a process which can achieve an effective, stable and clear substantially nonalcoholic aqueous pharmaceutical composition. A further objective of the present invention is to provide a method for solubilizing substances not normally soluble in water to form an aqueous substantially nonalcoholic preparation.
SUMMARY OF THE INVENTION
The present invention is directed to a process of converting a alcoholic/aqueous pharmaceutical preparations into aqueous nonalcoholic or reduced alcoholic solutions by distillation to remove alcohol(s). Particular, the invention comprises the introduction of a distillation method, which produces nonalcoholic or reduced alcoholic pharmaceutical preparations, formulated in the presence of alcohol. More particularly this invention relates to the removal of alcohol(s) from a pharmaceutical preparation through the process of distillation resulting in the production of an effective mouthwash, oral rinse and other pharmaceutical preparation used in maintaining oral hygiene. Further, the process can be used to prepare aqueous, substantially non-alcoholic preparation of active ingredients that normally are soluble in alcohols and do not dissolve in water.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
The present invention provides a process of removing alcohol from a pharmaceutical preparation resulting in a non-alcoholic composition or reduced alcoholic composition that is effective and physically and chemically stable.
The process of heating a liquid until its more volatile constituents pass into vapor phase and in turn separate from a mixture of several components is known as distillation. Distillation has been utilized in a number of chemical applications for the use of separating components within a mature. In contrast, however, the present invention uses the process of disillusion to remove alcohol(s) from alcoholic/aqueous pharmaceutical preparations and thus provide a substantially nonalcoholic aqueous pharmaceutical preparation formulated in the presence of alcohol, which is chemically and physically stable in the absence of alcohol. In other words, the distillation process of the subject invention is used to formulate a substantially nonalcoholic/aqueous pharmaceutical that was, formulated in the presence of alcohol.
A pharmaceutical preparation is dissolved and formulated by conventional means with the use of alcohol(s). The alcohol(s) used in the present invention may have various forms. Typically, the alcohol(s) used in the invention are alcohol(s) having a boiling point of less than water (100° C.), and preferably an alcohol having a boiling point less than 80° C. Methanol (boiling point 65° C.) and/or ethanol (boiling point 78.5° C.) are alcohols particularly useful in the present invention because their boiling points are lower than water (boiling point 100° C.). Alcohol(s) which may be used in connection with the subject invention may be alcohol(s) having 1 or more carbon atoms. Preferably, alcohol having 1 to 3 carbons and more preferably alcohol having 1 to 2 carbon atoms are used in connection with the practice of the present invention. As such, the most preferred alcohol(s) are ethanol and/or methanol. Furthermore, the typical levels of alcohol used in the pre
Henley III Raymond
Welsh & Katz Ltd.
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