Formulations and Treatment Methods

Abstract

The invention provides compositions comprising formula 1 steroids, e.g., 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate and one or more excipients, including compositions that comprise a liquid formulation comprising less than about 3% v / v water. The compositions are useful to make improved pharmaceutical formulations. The invention also provides methods of intermittent dosing of steroid compounds such as analogs of 16α-bromo-3β-hydroxy-5α-androstan-17-one and compositions useful in such dosing regimens. The invention further provides compositions and methods to inhibit pathogen replication, ameliorate symptoms associated with immune dysregulation and to modulate immune responses in a subject using the compounds. The invention also provides methods to make and use these immunomodulatory compositions and formulations.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from and is a continuation application of pending U.S. application Ser. No. 10 / 877,911, filed Jun. 24, 2004, which is a continuation of pending U.S., application Ser. No. 09 / 820,483, which is a continuation-in-part of: (1) pending U.S. application Ser. No. 09 / 449,184, filed Nov. 24, 1999, which claims priority to abandoned U.S. provisional application Ser. No. 60 / 109,924, filed Nov. 24, 1998, and (2) pending U.S. application Ser. No. 09 / 414,905, filed Oct. 8, 1999, which claims priority to abandoned U.S. provisional application Ser. No. 60 / 140,028, filed Jun. 16, 1999 and (3) pending U.S. application Ser. No. 09 / 449,004, filed Nov. 24, 1999, which claims priority to abandoned U.S. provisional application Ser. No. 60 / 109,923, filed Nov. 24, 1998, and (4) U.S. application Ser. No. 09 / 535,675, filed Mar. 23, 2000, now U.S. Pat. No. 6,667,299 B1, which claims priority to abandoned U.S. provisional applicatio...

AI Technical Summary

Benefits of technology

[0040] Other embodiments include a method to enhance the expression of one or more cytokines or interleukins that facilitate Th1 immune responses in a subject or to reduce the expression of one or more cytokines or interleukins that facilitate Th2 immune response in a subject comprising administering to the subject an effective amount of a formula 1 compound, whereby the subject's Th1 immune response is enhanced of the subject's undesired Th2 immune response is reduced.

Problems solved by technology

Some of these compositions may have undesired or suboptimal properties.

For example, solvents such as dioxane, DMSO or chloroform are generally not preferred or suitable parenteral excipients, particularly for human use.

Impaired production can result from causes such as chemotherapies or radiation therapies.

Abnormal loss of circulating platelets is often associated with autoreactive antibodies that bind to platelets and reduce their life span.

For example, infusion of IgG antibodies is not always effective and the treatment is relatively expensive.

Other treatments, such as prednisone are also not always effective and they typically are discontinued or tapered off after several weeks due to toxicity or unwanted side effects.

Splenectomy, which is relatively expensive and invasive, is also not always effective.

Administration of proteins is typically expensive, given factors such as the complexity of producing pharmaceutical grade material.

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