Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-11-24
2001-11-13
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C514S772300
Reexamination Certificate
active
06316019
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a process for adding pharmaceutically active compounds to substrates. The present invention is particularly useful for substrates used in the manufacture of disposable absorbent articles, specifically suited for substrates used in the manufacture of tampons.
There are several methods of delivering pharmaceutically active compounds to their intended targets, including but not limited to oral, topical, and transdermal. Disposable absorbent articles can be used as vehicles for topical delivery to the vaginal canal, perineum, and related areas, as well as for treatment sites for the discharged fluids to come in contact with the pharmaceutically active compounds, as they are captured by the product.
Duchane, U.S. Pat. No. 3,796,219, discloses a water-soluble, thermoplastic composition for hygienic and medical applications, such as for use as an insertion aid coating for tampons and as the matrix structure for suppositories. The coating is stable in temperatures up to 65° C., and it provides lubricity at temperatures below 65° C. when exposed to shear forces, such as those present during insertion of the tampon. Duchane discloses the use of two olefinic diols, polyethylene glycol and propylene glycol in combination with hydroxypropyl cellulose (HPC) having a molecular weight of approximately 75,000. The resulting composition is stable at temperatures up to 65° C.
Von Bittera et al., U.S. Pat. No. 4,582,717, discloses a process for producing vaginal tampons containing a pharmaceutically active compound. The process involves preparing a material containing the active compound and additional formulation auxiliaries, heating the material to a temperature in excess of 40° C., cooling the melt to 40° C., and then injecting the cooled material into pre-warmed tampons. One of the formulation auxiliaries disclosed in von Bittera is polyethylene glycol (PEG) having moderate molecular weight.
A common theme of the art shown above is the attempt to provide a coating that is stable above room temperature, but is liquid at or near body temperature (37° C.).
Brown-Skrobot, U.S. Pat. No. 5,679,369, discloses additives to tampons to inhibit the production of toxic shock syndrome toxin-1. The additives generally are not liquid at or near room temperature, and therefore, they require a carrier material, such as isopropyl alcohol. This technology represents an important advance in the art, but the disclosed process of applying the additive may require a recovery process to capture the volatile alcohol.
All of the art above requires either the use of significant energy or a volatile carrier material, to apply their respective coatings; thus a need still exists for a process for adding pharmaceutically active compounds to substrates or articles of manufacture, without the limiting requirements as stated.
SUMMARY OF THE INVENTION
The present invention relates to a solution of an olefinic diol and a pharmaceutically active compound that is liquid at a temperature of less than about 35° C., to the solution's preparation, and to its use. This solution is useful in low temperature addition of the pharmaceutically active compound to articles of manufacture. In accordance with one embodiment of the present invention, the solution is applied to a substrate at a temperature of less than 40° C. In another embodiment of the present invention, the solution is applied to a disposable absorbent article at a temperature of less than 40° C. A third embodiment involves applying the solution to a fluid permeable material at a temperature of less than 40° C. and encasing at least a portion of an absorbent material with the fluid permeable material. The invention also relates to a disposable absorbent article containing an additive, wherein the additive comprises the solution described above.
The pharmaceutically active compound of the present invention is selected from the group consisting of:
i) monoesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms and wherein said monoester has at least one hydroxyl group associated with its aliphatic alcohol residue;
ii) diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms and wherein said diester has at least one hydroxyl group associated with its aliphatic alcohol residue; and
iii) mixtures of said monoesters and diesters.
REFERENCES:
patent: 3595236 (1971-07-01), Apleton et al.
patent: 3724465 (1973-04-01), Duchane
patent: 3756238 (1973-09-01), Hanke
patent: 3791902 (1974-02-01), Hanke et al.
patent: 3796219 (1974-03-01), Hanke
patent: 3821350 (1974-06-01), Suchane
patent: 4347237 (1982-08-01), Evenstad et al.
patent: 4582717 (1986-04-01), von Bittera et al.
patent: 4952211 (1990-08-01), Snider
patent: 4981686 (1991-01-01), Hardy
patent: 5417224 (1995-05-01), Petrus et al.
patent: 5550145 (1996-08-01), Olund et al.
patent: 5679369 (1997-10-01), Brown-Skrobot
patent: 5686097 (1997-11-01), Taskovich et al.
patent: 5753252 (1998-05-01), Brown-Skrobot
patent: 0 395 099 A2 (1990-10-01), None
patent: 0 483 835 A1 (1992-05-01), None
patent: 0 725 183 A2 (1996-08-01), None
patent: 2 691 067 (1993-11-01), None
EPO Search Report.
Azpuru Carlos A.
Mc-Neil-PPC, Inc.
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