Pharmaceutical treatments and compositions

a technology of compositions and pharmaceutical treatments, applied in the field of pharmaceutical treatments and compositions, can solve the problems of impaired production, undetectable or suboptimal properties of compositions, and general inability to prefer or suitable parenteral excipients such as dioxane, dmso or chloroform, etc., to facilitate th1 immune response, enhance the expression of one or more cytokines, and reduce the expression of on

Inactive Publication Date: 2007-06-07
BIOVIE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0045] 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 facil

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

Method used

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  • Pharmaceutical treatments and compositions
  • Pharmaceutical treatments and compositions
  • Pharmaceutical treatments and compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[1078] BrEA Formulation. Two lots of a non-aqueous BrEA formulation were made at a BrEA concentration of 50 mg / mL in 25% polyethylene glycol 300, 12.5% dehydrated ethyl alcohol, 5% benzyl benzoate, and 57.5% propylene glycol as follows. BrEA was obtained from Procyte, Inc. The remaining excipients are shown below.

SupplierFinal ProductExcipientSpecificationLot No.ConcentrationPropylene glycolUSPArco Chemical57.5% (v:v)HOC-61220-01104Polyethylene glycolNFUnion Carbide  25% (v:v)300695752Dehydrated alcoholUSPMcCormick12.5% (v:v)Distilling 97K10Benzyl benzoateUSPSpectrum  5% (v:v)PharmaceuticalsMG025

[1079] The formulation was prepared by suspending BrEA in polyethylene glycol 300, and sequentially adding propylene glycol, benzyl benzoate, and dehydrated ethyl alcohol to form a solution, which was diluted to the final desired volume with additional propylene glycol. The procedure is described below.

[1080] The calculated amount of polyethylene glycol 300 was added to a compounding vess...

example 2

[1083] BrEA drug substance and BrEA formulation stability. An accelerated stability study of 6 months duration is conducted using BrEA and the formulations from example 1. Samples are taken at 1, 2, 3, 4, 5, and 6 month time points and compared with the specifications listed in example 1. Real time stability (25° C., 60% relative humidity) is conducted using BrEA formulation Lots 1 and 2, with sampling time points at 3, 6, 9, 12, 18, 24, and 36 months. After 3 months of storage at 40° C. and 75% relative humidity, the assay potency of BrEA is at least 95% of the label value. The results from the stability testing indicate that BrEA is stable for at least 3 months at elevated temperature and humidity in the Lot 1 and 2 formulations.

example 3

[1084] Primate intermittent dosing protocol. Pig-tail macaque monkeys infected with the SHIV229 retrovirus were treated with a BrEA formulation as described in example 1. SHIV229 is a recombinant retrovirus containing HIV and SIV sequences. J. Thompson et al., abstract #75, 16th Annual Symposium on Nonhuman Primate Models for AIDS, Oct. 7-10, 1998, Atlanta, Ga., M. Agy et al., abstract #67, 16th Annual Symposium on Nonhuman Primate Models for AIDS, Oct. 7-10, 1998, Atlanta, Ga. In monkeys, it establishes an aggressive infection that leads to severe symptoms of end-stage disease in infected untreated animals at about 180-210 days after infection. Four pig-tail macaques (2 / group) received subcutaneous injections of the formulation at 1 or 2 mg / kg body weight for 10 consecutive days (Protocol 1). On week 8, 3 of the 4 monkeys were retreated and 2 treatment naïve monkeys were treated with 5 mg / kg of the formulation on an every other day basis for a period of 20 days (Protocol 2). On wee...

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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 is a continuation application and claims priority of pending U.S., application Ser. No. 09 / 820,483, which is 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 application Ser. No. 60 / 126,056, filed Mar. 23, 1999, and abandoned U.S. provisional application Ser. No. ...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K31/704A61K31/58A61K31/66A61K31/56
CPCA61K31/56C07J1/0011C07J1/0025C07J31/003C07J31/006A61P35/00Y02A50/30
Inventor AHLEM, CLARENCEFRINCKE, JAMESCARVALHO, LUIS DANIELHEGGIE, WILLIAMPRENDERGAST, PATRICKREADING, CHRISTOPHERTHADIKONDA, KRUPAKARVERNON, RUSSELL
Owner BIOVIE INC
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