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Prostaglandin compositions and methods of treatment for male erectile dysfunction

A technology of prostaglandin and composition, which is applied in the direction of drug combination, disease, drug delivery, etc., and can solve problems such as unstable work and complexity

Inactive Publication Date: 2004-12-01
NEXMED HLDG INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, prostaglandin E 1 Ease of transformation through reforming and other reactions
This relative instability complicates efforts to formulate compositions suitable for intrascaphoid delivery

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Example 1: Topical Prostaglandin E 1 Composition A

[0114] Composition A was prepared as follows. By dissolving 0.4 parts by weight of prostaglandin E in 5 parts by weight of ethanol 1 (Alprostadil USP) Part A of the composition was prepared. Next, 5 parts by weight of 2-(N,N-dimethylamino)-dodecyl propionate was mixed into the alcohol-prostaglandin E 1 Solution, then add 5 parts by weight of ethyl laurate.

[0115] Part B was prepared starting with water / buffer at pH 5.5. Water / buffers were prepared by adding sufficient potassium phosphate monohydrate to pure water to make 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 accounted for 80 parts of the total composition. All parts specified herein are parts by weight.

[0116] 0.5 parts by weight of ethyl laurate was added to the buffer. Next, locust bean gum (in powder form) was dispersed into the buffer ...

Embodiment 2

[0123] Example 2: Topical Prostaglandin E 1 Composition B

[0124] 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 Relatively rapid and constant delivery. The results are listed in Table 2 below and image 3 middle.

Embodiment 3

[0125] Example 3: Topical Prostaglandin E 1 Composition C

[0126] 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 little or no effect on the consistency and appearance, which was virtually 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 sustained constant delivery, 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, as well as suitable applicators. 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, aliphatic C2 to C30 ester, 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.

Description

[0001] related application [0002] This application is a continuation-in-part of pending application Serial No. 09 / 947,617, filed September 6, 2001, the contents of which are incorporated herein by reference. [0003] technical field of invention [0004] The present invention relates to compositions and methods for treating erectile dysfunction, more particularly to methods and pharmaceutical compositions for administering intranavicular vasodilators to the navicular fossa of patients. Background of the invention [0005] The term "impotence" refers to a male's inability to achieve and maintain an erection of the penis sufficient for satisfactory sexual intercourse. "Erectile dysfunction" is the more precise term to express "refers to the male's inability to achieve penile erection as part of the multifaceted process of overall male sexual function", see Droller, M.J. et al. Impotence.Consensus Development Conference Statement, National Institutes of Health (1993). [000...

Claims

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Application Information

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IPC IPC(8): A61K47/10A61K9/00A61K31/215A61K31/223A61K31/557A61K31/5575A61K45/00A61K45/06A61K47/14A61K47/18A61K47/26A61K47/36A61P15/10A61P43/00
CPCA61K47/36A61K47/183A61K47/18A61K31/5575A61K9/0014A61K47/14A61K47/10A61K9/0034A61K45/06A61K31/557A61P15/10A61P43/00A61K2300/00
Inventor 詹姆斯·L·亚格那迪·布亚迪金瑟维特·布亚迪金
Owner NEXMED HLDG INC