Semisolid topical hormonal compositions and methods for treatment
First Claim
1. A method for determining the initial dose to administer to a human subject of a semisolid topical composition having a pH value of between about 4 to about 8 and comprising 0.1% to about 2% w/w of a human sex hormone, a penetration-enhancing amount of oleic acid;
- a C1-C4 alcohol; and
a glycol, said method comprising;
determining the body weight of the subject;
selecting the dose according to a predetermined empirical relationship between the body weight, the applied dosage, and the serum level of the hormone in a reference population at steady state.
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Abstract
Semisolid topical pharmaceutical compositions comprising a therapeutically effective amount of a mammalian hormone and an effective amount of a penetration enhancer and methods for their use are provided. The pharmaceutical compositions and methods for their use can provide blood or plasma levels of the administered hormone within a predetermined or normal range of hormone values. In particular embodiments, the hormone is testosterone or estrogen and the amount to be applied to the skin of the subject is determined according to the weight or body mass index of the subject. The topical composition can be formulated in solutions, creams, lotions, ointments, and gels.
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Citations
44 Claims
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1. A method for determining the initial dose to administer to a human subject of a semisolid topical composition having a pH value of between about 4 to about 8 and comprising 0.1% to about 2% w/w of a human sex hormone, a penetration-enhancing amount of oleic acid;
- a C1-C4 alcohol; and
a glycol, said method comprising;
determining the body weight of the subject;
selecting the dose according to a predetermined empirical relationship between the body weight, the applied dosage, and the serum level of the hormone in a reference population at steady state. - View Dependent Claims (2, 3, 4, 5, 6, 29)
- a C1-C4 alcohol; and
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7. A method for determining the dose to administer to a human subject of a semisolid topical composition comprising a therapeutic amount of a mammalian hormone and an effective amount of a penetration enhancer, said method comprising:
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determining the weight and height of the subject;
calculating the Body Mass Index (BMI) of the subject;
and adjusting the dose according to the BMI. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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30. A method of restoring serum sex hormone levels in a human subject to normal levels, said method comprising:
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determining the height and weight of the subject;
using the height and weight of the subject to estimate a first dose amount of a topical composition comprising the sex hormone and a penetration enhancer;
applying at least daily to the skin of the subject the composition in the first dose amount;
measuring the level of the sex hormone in the blood of the subject; and
if the blood sex hormone level is below a first predetermined level, treating the subject with a second dose 25 to 100% greater than the first dose amount;
or, if the blood sex hormone level is above or near a second predetermined level, treating the subject with a third dose which is 25 to 75% less than the first dose amount - View Dependent Claims (31, 32, 33, 34, 35, 36, 37)
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38. A metered device for delivering a topical composition comprising testosterone and a penetration enhancer to a subject, wherein said metered device provides an identical amount of the composition on each administration and wherein the amount administered is determined by the BMI of the subject.
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39. The kit comprising:
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a pharmaceutical composition comprising a therapeutic amount of a mammalian hormone and an effective amount of a skin penetration enhancer;
a metered dose pump holding said composition in an amount to provide more than one dose;
said pump set to deliver a fixed amount of the pharmaceutical composition when the pump is activated. - View Dependent Claims (40, 41)
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42. A method for determining the dose to administer to a human subject of a semisolid topical composition comprising a therapeutic amount of a mammalian hormone and an effective amount of a penetration enhancer, said method comprising:
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determining the body weight and height of the subject;
and adjusting the dose according to the body weight. - View Dependent Claims (43)
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44. A method of adjusting serum sex hormone levels in a human subject to normal levels, said method comprising:
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determining the weight of the subject;
using the weight of the subject to establish a first dose amount of a topical composition comprising the sex hormone and a penetration enhancer wherein the establishing is based upon a predetermined empirical relationship between body weight, the amount of the composition applied, and the serum hormone concentration level measured in a reference population at steady state;
applying at least daily to the skin of the subject the composition in the first dose amount;
measuring the level of the sex hormone in the blood of the subject; and
if the blood sex hormone level is below a first predetermined level treating the subject with a second dose 25 to 100% greater than the first dose amount;
or if the blood sex hormone level is above or near a second predetermined level, treating the subject with a third dose which is 25 to 75% less than the first dose amount.
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Specification