System for use by compounding pharmacists to produce hormone replacement medicine customized for each customer

Abstract

This invention provides a system for compounding a pharmaceutical product for hormone replacement therapy. The system has a set of concentrated reagent compositions, each containing one or more steroid hormones dissolved in one or more solvents. The needs of each consumer are ascertained, and a pharmaceutical product is compounded for them using the concentrated reagent compositions. Each product has a custom tailored combination of steroid hormones at a concentration that is therapeutically effective for the consumer in accordance with their needs.

1 . A method of compounding a pharmaceutical product for hormone replacement therapy, whereby each product is custom tailored according to the needs of each individual consumer, the method comprising: (a) obtaining a plurality of concentrated reagent compositions, each comprising one or more steroid hormones dissolved in one or more solvents, wherein at least one of the concentrated hormone reagent compositions in the plurality contains a hormone that is not in other reagent compositions in the plurality; (b) ascertaining the needs of an individual consumer; (c) compounding concentrated reagent compositions selected from the plurality into a pharmaceutical product such that: the pharmaceutical product has a ratio of steroid hormones that is custom tailored for said consumer; and the pharmaceutical product contains a total concentration of steroid hormones that is therapeutically effective for the consumer in accordance with their needs. 
     
     
         2 . The compounding method of  claim 1  wherein step (b) is accomplished by way of a prescription from a doctor for replacement of particular hormones in said individual each in a particular amount. 
     
     
         3 . The compounding method of  claim 1  wherein the concentrated reagent compositions compounded in step (c) include a plurality of concentrated reagent compositions, each containing a different estrogen dissolved at a total concentration of at least 40 mg per gram. 
     
     
         4 . The compounding method of  claim 1  wherein the concentrated reagent compositions compounded in step (c) include a reagent composition that contains a plurality of estrogens dissolved at a total concentration of between 10 and 60 mg of estrogens per gram. 
     
     
         5 . The compounding method of  claim 1  wherein the concentrated reagent compositions compounded in step (c) include a reagent composition that contains at least one androgen dissolved at a concentration of at least 150 mg per gram, wherein said androgen is selected from testosterone and dehydroepiandrosterone (DHEA). 
     
     
         6 . The compounding method of  claim 1  wherein the concentrated reagent compositions compounded in step (c) include a reagent composition that contains at least one progestagen dissolved at a concentration of at least 200 mg per gram, wherein said progestagen is selected from progesterone and pregnenolone. 
     
     
         7 . The compounding method of  claim 1  whereby the pharmaceutical product produced according to the method contains estriol, estradiol, and estrone at a ratio of 8:1:1, 5:4:1, 6:3:1, or 7:2:1 by weight. 
     
     
         8 . A reagent system for compounding pharmaceutical products containing multiple steroid hormones for use in hormone replacement therapy, wherein the system allows each of such products to be custom tailored for each individual consumer; wherein the system comprises a plurality of concentrated hormone reagent compositions, each of which contains one or more steroid hormones selected from the group consisting of estrogen (estriol, estradiol, or estrone), progesterone, testosterone, dehydroepiandrosterone, norethisterone acetate, norgestrel, levonorgestrel gestodene CPA chlormadinone acetate, drospirorenone, and 3-ketodesogestrel dissolved in one or more solvents selected from the group consisting of propylene glycol, ethoxy diglycol, glycerin, mineral oil, fixed oil, emu oil, peanut oil, vitamin E oil, acetone, amylene hydrate, benzyl benzoate, corn oil, cottonseed oil, diethylene glycol monoethyl ether, ethyl acetate, isopropyl alcohol, methyl alcohol, methylene chloride, methyl isobutyl ketone, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 600, sesame oil, alcohol, a 50% ethoxy diglycol (diethylene glycol mono-ethyletherand) 50% propylene glycol mixture and water; wherein concentrated hormone reagent composition in the system contains hormones that are different from what is in other concentrated hormone reagent compositions in the system and wherein the hormone concentration in each concentrated hormone reagent composition is from about 0.6% to about 80%; and wherein each of said reagent compositions comprises a sufficient concentration of said one or more hormones such that when combined with other compositions in the system to form a custom tailored pharmaceutical product, the concentration of said hormones in the product is sufficient to be therapeutically effective for the consumer in accordance with their needs. 
     
     
         9 . The pharmaceutical compounding system of  claim 8  wherein at least one of said concentrated hormone reagent compositions is a concentrated solution of one or more estrogens. 
     
     
         10 . The pharmaceutical compounding system of  claim 8  wherein each of said concentrated reagent compositions is contained in a graduated dispensing device. 
     
     
         11 . The pharmaceutical compounding system of  claim 8  wherein at least one of said concentrated reagent compositions contains a plurality of different estrogens dissolved at a total concentration of between 10 and 60 mg of estrogens-per gram. 
     
     
         12 . The pharmaceutical compounding system of  claim 8  wherein at least one of said concentrated reagent compositions contains at least one androgen dissolved at a concentration of at least 150 mg per gram. 
     
     
         13 . The pharmaceutical compounding system of  claim 8  wherein at least one of said concentrated reagent compositions contains at least one progestagen dissolved at a concentration of at least 200 mg per gram. 
     
     
         14 . The pharmaceutical compounding system of  claim 8  comprising a concentrated reagent composition containing estriol, a concentrated reagent composition containing estradiol, and a concentrated reagent composition containing estrone. 
     
     
         15 . The pharmaceutical compounding system of  claim 8  wherein each of the concentrated hormone reagent compositions contain a different colorant corresponding to the identity of the hormones in the reagent compositions. 
     
     
         16 . The pharmaceutical compounding system of  claim 8  wherein each of the concentrated hormone reagent compositions contain a colorant in order to determine after compounding whether the ingredients of the product have been adequately mixed according to whether the final product is a uniform color throughout. 
     
     
         17 . A kit comprising the concentrated reagent compositions of the pharmaceutical compounding system of  claim 8 . 
     
     
         18 . A method for preparing the pharmaceutical compounding system of  claim 8 , comprising for each of said reagent compositions: (a) combining steroid hormones with said solvents; and (b) processing said combination in an ointment mill or homogenizer to achieve complete dissolution of said hormones in the solvents. 
     
     
         19 . A method of hormone replacement therapy comprising: (a) ascertaining the individual needs of a consumer for replacement or supplementation of one or more hormones; (b) compounding a pharmaceutical product according to the method of  claim 1 , whereby the product is customized to the individual needs of the consumer ascertained in step (a); and (c) providing said pharmaceutical product to the consumer. 
     
     
         20 . A method of hormone replacement therapy comprising: (a) ascertaining the individual needs of a patient for replacement or supplementation of one or more hormones; and (b) prescribing for the patient a pharmaceutical product to be compounded according to the method of  claim 1  such that the product will be customized to the individual needs of the patient. 
     
     
         21 . A method of quality control of a customized pharmaceutical product intended for hormone replacement therapy comprising: (a) obtaining a pharmaceutical product compounded according to the method of  claim 1  using one or more concentrated reagent compositions containing a colorant; (b) observing the color of the pharmaceutical product after compounding; (c) deducing the identity of the hormones in the product from said color; and (d) comparing the hormones in the product with the hormones that need supplementation in a particular consumer. 
     
     
         22 . A method of quality control of a customized pharmaceutical product intended for hormone replacement therapy comprising: (a) obtaining a pharmaceutical product compounded according to the method of  claim 1  using one or more concentrated reagent compositions containing a colorant; (b) observing the color of the pharmaceutical product after compounding; and (c) determining whether the ingredients of the product have been adequately mixed according to whether the final product is a uniform color throughout.