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Emulsion composition comprising prostaglandin E1

A composition, the technology of polyoxyethylene sorbitan ester, is applied in the field of emulsified composition, and can solve the problems such as inability to provide enhancement, increase cycle time, etc.

Active Publication Date: 2008-09-24
TAIWAN LIPOSOME CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to this particular example, lecithin, phosphatidylcholine with a purity of 70%, was used to enhance circulation time; however, dipalmitoyl phosphatidylcholine (DPPC) with a higher purity did not provide this enhancement.

Method used

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  • Emulsion composition comprising prostaglandin E1
  • Emulsion composition comprising prostaglandin E1
  • Emulsion composition comprising prostaglandin E1

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Including PGE 1 And preparation of the emulsified composition TLC01 of Polysorbate 80 (Polysorbate 80)

[0038] Prepare PGE including formula (I) in this example 1 And a non-proton-donating surfactant, an emulsified composition of polyoxyethylene sorbitan 80. A method similar to this embodiment can also be used to prepare any other PGE 1 And the emulsified composition of non-proton-donating surfactant.

[0039] PGE of formula (I) 1 Other chemicals were purchased from Sigma (USA). Polyoxyethylene sorbitan ester 80 was purchased from Sigma Company (USA), NOF Company (Japan) or Imperial Chemical Industries PLC (London, UK). MCT oil (a mixture of triglycerides, the fatty acids in the glyceride structure mainly contain not less than about 95% caprylic acid and capric acid), such as LIPOID purchased from Lipoid GmbH (Germany) Or Panacet purchased from NOF (Japan) . Lecithin acylcholine (EPC) (purity: 95-100% and purity: 80-85%) was purchased from Avanti (USA), NOF (Japan), or L...

Embodiment 2

[0042] Including PGE 1 And preparation of emulsified composition of non-proton-donating surfactant

[0043] Different emulsified compositions were prepared using a method similar to that described in Example 1. These emulsified compositions include PGE 1 And different non-proton-donating surfactants.

[0044] Non-proton-donating surfactants are obtained from various sources. Polyethylene glycol-15-hydroxystearate ( HS15) and Polyoxyl 35 castor oil ( EL) was obtained from BASF, Germany. D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS) was obtained from Eastman Company, USA. 3-(N,N-Dimethylpalmitylammonium)propanesulfonate and dodecyltrimethylammonium bromide were obtained from Sigma, USA. DSPE-mPEG 2000 was purchased from Avanti Company in the United States or NOF Company in Japan.

[0045] The ingredients and amounts of various emulsified compositions are listed in Table I.

[0046] Table I Composition and amount of emulsified composition

[0047]

[0048]

[0049]...

Embodiment 3

[0051] PGE in emulsified composition 1 Determination of storage stability

[0052] In this example, the PGE in the array of emulsion composition was measured 1 The storage stability. Use a method similar to this example to determine the inclusion of PGE 1 Any PGE in any emulsion composition of 1 The storage stability.

[0053] Use commercially available products (Mitsubishi Pharmaceutical Co., Ltd. (Tokyo, Japan)) as a control group for comparison with emulsified compositions according to specific examples of the present invention. The ingredients and amounts of various emulsified compositions are listed in Table I for comparison.

[0054] PGE in an emulsified composition stored in a sealed transparent ampoule and placed in a dark place 1 The stability of the emulsified composition is the residual PGE measured by HPLC analysis after storage at 40°C for one week or one month 1 Expressed as a percentage. PGE in the emulsified composition 1 The stability of the product can also be o...

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Abstract

An emulsion composition includes prostaglandin E 1 (PGE 1 ), a phospholipid with a high purity and a non-proton-providing surfactant that improves stability of PGE 1 . Embodiments of the emulsion composition include an effective amount of PGE 1 , about 1 % to about 30% (w / w) of a pharmaceutically acceptable oil as an oil base based on the weight of the emulsion composition, about 1% to about 30% (w / w) of a phospholipid with a high purity based on the weight of the oil base, about 1.6% to about 40% (w / w) of a non-proton-providing surfactant based on the weight of the oil base, and the balance of the emulsion composition being water.

Description

Technical field [0001] The present invention relates to an emulsified composition, in particular, to a 1 (PGE 1 ) The emulsified composition. Background technique [0002] Prostaglandins are hormone-like substances that participate in a wide range of body functions such as contraction and relaxation of smooth muscle, expansion and contraction of blood vessels, control of blood pressure, inhibition of platelet aggregation, and regulation of inflammation. Therefore, prostaglandins have been developed as agents or therapeutic compounds to treat hypertension, thrombosis, asthma, and gastrointestinal ulcers, induce labor and abortion in pregnant animals, and prevent atherosclerosis. [0003] There have been many improvements related to the stability improvement of prostaglandin emulsions or other properties related to the therapeutic function of prostaglandin emulsions. Japanese Patent Publication JP59141518 discloses prolonged prostaglandin A 1 (I.e. Prostaglandin A 1 , PGA 1 ) Prost...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/107A61K47/24A61K47/34A61P1/04A61P7/02A61P9/12A61P11/06A61P15/04
CPCA61K31/5575A61K9/0019A61K9/107A61K9/1075A61P1/00A61P1/04A61P11/06A61P15/04A61P21/02A61P29/00A61P7/02A61P9/08A61P9/10A61P9/12Y02A50/30A61K47/34A61K47/44
Inventor 洪基隆甘霈林一峰
Owner TAIWAN LIPOSOME CO LTD
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