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Prostaglandin compositions and method of treatment for male erectile dysfunction

An erectile dysfunction, prostaglandin technology, applied in drug combinations, sexual diseases, drug delivery, etc., can solve problems such as complication, unstable effort, etc.

Inactive Publication Date: 2003-01-29
NEXMED HLDG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This relative instability complicates efforts to formulate compositions suitable for intrascaphoid delivery

Method used

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  • Prostaglandin compositions and method of treatment for male erectile dysfunction
  • Prostaglandin compositions and method of treatment for male erectile dysfunction
  • Prostaglandin compositions and method of treatment for male erectile dysfunction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Example 1: Topical Prostaglandin E 1 Composition A

[0092] Composition A was prepared as follows. by dissolving 0.4 parts prostaglandin E in 5 parts ethanol 1 (Alprostadil USP) Part A was prepared. In the next step, 5 parts of 2-(N,N-dimethylamino)-dodecyl propionate were mixed into the alcohol-prostaglandin E 1 solution, followed by the addition of 5 parts of ethyl laurate.

[0093] Part B was prepared starting with water / buffer at pH 5.5. Water / buffers were prepared by adding sufficient potassium phosphate monohydrate to purified water to produce a 0.1M solution. The water / buffer pH was adjusted to 5.5 with a strong base solution (1 N sodium hydroxide) and a strong acid (1 N phosphoric acid). Buffer represents 80 parts of the total composition.

[0094] Add 0.5 parts of ethyl laurate to the buffer. In the next step, locust bean gum (in powder form) was dispersed into the buffer and homogenized using a homogenizer. Table 1 below contains a list of the compone...

Embodiment 2

[0100] Example 2: Topical Prostaglandin E 1 Composition B

[0101] Composition B was prepared using the ingredients listed in Table 1. Composition B contains more prostaglandin E than composition A 1 . Composition B exhibited a similar semi-solid consistency and uniform appearance despite the increased drug dosage. Determination of prostaglandin E according to the method described in Example 1 1 permeability. Composition B provides prostaglandin E 1 The relatively rapid and constant delivery of , the results are listed in Table 2 below and image 3 middle.

Embodiment 3

[0102] Example 3: Topical Prostaglandin E 1 Composition C

[0103] Composition C was prepared using the ingredients listed in Table 1. Composition C contains more prostaglandin E than compositions A or B 1 . Increased drug levels had less (or no) effect on consistency and appearance and were actually comparable to compositions A or B. Still measure prostaglandin E according to the method described in embodiment 1 1 permeability. According to this test, composition C also provides prostaglandin E 1 The relatively rapid and constant delivery of , the results are listed in Table 2 below and image 3 middle.

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Abstract

The invention provides methods of treating erectile dysfunction comprising the step of placing within the fossa navicularis of the patient an effective erection-inducing amount of a prostaglandin E1 composition of a semi-solid consistency. The composition comprises prostaglandin E1, a penetration enhancer, a polysaccharide gum, a lipophilic compound, and an acidic buffer system. The penetration enhancer is an alkyl-2-(N,N-disubstituted amino)-alkanoate ester, an (N,N-disubstituted amino)-alkanol alkanoate, or a mixture of these. The lipophilic compound may be an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, or a mixture of these. The composition includes a buffer system capable of providing a buffered pH value for said composition in the range of about 3 to about 7.4.

Description

field of invention [0001] The present invention relates to compositions and methods suitable for treating erectile dysfunction, and more particularly to methods and pharmaceutical compositions suitable for intrascaphoid administration to the scaphoid fossa of a patient. Background of the invention [0002] The term "impotence" is used to describe a male's inability to achieve and maintain an erection of the penis sufficient for satisfactory sexual intercourse. The term "erectile dysfunction" has been suggested as a more accurate term "denoting a male's inability to achieve penile erection as part of a multifaceted approach to overall male sexual function." Droller, M.J. et al. Impotence. Consensus Development Conference Statement, National Institutes of Health (1993). [0003] The cause of erectile dysfunction may be psychological (psychogenic erectile dysfunction) or organic or both. Organ causes include physiological, neurological, vascular and hormonal pathologies or co...

Claims

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Application Information

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IPC IPC(8): A61K47/10A61K9/00A61K31/557A61K31/5575A61K45/06A61K47/14A61K47/18A61K47/26A61K47/36A61P15/10A61P43/00
CPCA61K47/36Y10S514/946A61K47/18A61K31/5575A61K47/183Y10S514/947A61K9/0014A61K47/14A61K47/10A61K9/0034A61K45/06A61K31/557A61P15/10A61P43/00A61K2300/00
Inventor 詹姆斯·亚格那迪·布亚迪金瑟维特·布亚迪金
Owner NEXMED HLDG INC
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