Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same

A composition and drug technology, applied in the field of hydrophobic drug delivery system and its composition, can solve the problem of inability to maintain blood drug concentration for a long time

Inactive Publication Date: 2008-07-09
CLARUS THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, even with improved instantaneous bioavailability, this drug delive...

Method used

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  • Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
  • Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
  • Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same

Examples

Experimental program
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Embodiment

[0136] Formulations 50 and 54 were administered to 6 patients: Formulation 50 was administered once daily ("QD") in two capsules (each containing the equivalent of 100 mg of T). Formulation 54 was administered as a once-daily or twice-daily ("BID") regimen of three capsules (each containing the equivalent of 66 mg of T). After 7 days of treatment according to the above three administration methods, the average drug-time curves of patients in each group are shown in Fig. 11 . The average drug-time curve of the preparation 54BID administration group was relatively stable within 24 hours, and its lowest value was about 70% of the peak value. Additional kinetic data for Formulation 54 dosed groups included:

[0137] The mean T concentration in the serum increased by 275 ng / dL from the baseline level

[0138] The mean T concentration in the serum is below the bottom limit of the normal range (ie, about 325 ng / dL)

[0139] Relatively fast release (Tmax about 1 hour)

[0140] The...

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Abstract

A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.

Description

[0001] priority statement [0002] This application claims priority to US Provisional Application 60 / 671,45460 / 671,454, filed April 15, 2005 and US Provisional Application 60 / 721,971, filed September 30, 2005, 60 / 721,971d. The disclosures in both applications are hereby incorporated by reference in their entirety. technical field [0003] The present invention relates to hydrophobic drug delivery systems and compositions thereof. The present invention also particularly relates to a pharmaceutical composition containing testosterone and its esters which can promote or prolong absorption and metabolism. Background technique [0004] Many pharmaceutically active orally administered compounds are poorly soluble in water, necessitating the formulation of these compounds in a delivery system that exhibits the desired kinetic performance in vivo. Poor oral bioavailability may render the drug ineffective, resulting in side effects of the drug and / or requiring high doses. Moreover...

Claims

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Application Information

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IPC IPC(8): A61K31/56
Inventor R·E·达得利P·P·康斯坦迪奈德斯
Owner CLARUS THERAPEUTICS INC
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