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Semisolid Compositions and Pharmaceutical Products

A semi-solid, composition technology, which is applied in the directions of drug combination, drug delivery, and non-active ingredient medical preparations, etc., can solve problems such as unsatisfactory drug dosage forms

Active Publication Date: 2016-09-28
PHOTOCURE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the method in US 2003 / 125388 has similarities with Levulan The same disadvantage of providing pharmaceutical dosage forms that require the actual administration of the pharmaceutical product to be formulated by a practitioner is often unsatisfactory

Method used

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  • Semisolid Compositions and Pharmaceutical Products
  • Semisolid Compositions and Pharmaceutical Products
  • Semisolid Compositions and Pharmaceutical Products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0174] Example 1 - Semisolid Compositions of the Invention

[0175] The preparation of the semi-solid composition of the present invention is as follows:

[0176] Caprylic / capric triglycerides ( 812, Sasol, Witten) and compounds c) to h), if present, were mixed with an overhead stirrer (IKA RW 20n, IKA Werke, Germany) at a stirring speed of 240 rpm and heated to 50 °C until a homogeneous liquid was formed. While stirring, the temperature was lowered to about 40°C and n-hexyl aminolevulinate (HAL) hydrochloride (HAL HCL, Phototherapy, Norway) was added. The mixture was homogenized for 1.5 minutes at 17500 rpm for optimal mixing. The mixture was then cooled to room temperature (about 21° C.) while continuing to stir. If the mixture becomes too viscous to beat with an overhead mixer, continue stirring by hand with a spatula instead.

[0177] The dropping point of the prepared product can be determined by the method described in European Pharmacopoeia 6.0 section 2.2.17. T...

Embodiment 2

[0188] Example 2: Stability

[0189] Compositions 30, 31, 32 and 33 were prepared as described in Example 1. Immediately after preparation, the compositions were visually assessed and the content of HAL HCl was determined by HPCL. 20 g of the compositions prepared in situ were transferred to clean glass containers with screw caps (three containers for each composition). Glass containers containing each composition were stored at 25°C / 60%RH, 30°C / 65%RH and 40°C / 75%RH for two months, respectively. Three samples were taken from each glass container after one month and the HAL HCl content was determined by HPLC. Determination of metaphase HAL HCl content. In addition, each composition was assessed visually.

[0190] time point: 0

[0191] combination

HAL HCl (%)

visual assessment

30

5.14

off-white

31

4.97

off-white

32

4.95

slightly lighter than off-white

33

5.06

slightly lighter than off-white

[019...

Embodiment 3

[0200] Embodiment 3: stability comparison

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Abstract

The present invention relates to the application of semi-solid composition and semi-solid pharmaceutical product in photodynamic therapy (PDT) cancer, precancerous lesion and noncancerous lesion of female reproductive system, anus and penis, especially suitable for endometrium, cervix, vulva , developmental abnormalities of the vagina, anus, and penis, and PDT for HPV infection of the uterus, cervix, vulva, vagina, anus, and cervix. The semi-solid composition and pharmaceutical product contain an active ingredient, which is 5-aminolevulinic acid (5-ALA) or a precursor or derivative of 5-ALA or a pharmaceutically acceptable salt thereof. The present invention also relates to a PDT method for the treatment of cancerous, precancerous and noncancerous lesions of the female reproductive system, anus and penis, wherein said semisolid composition and pharmaceutical preparation are used.

Description

technical field [0001] The present invention relates to a semi-solid composition and a semi-solid pharmaceutical product for photodynamic therapy (PDT) of cancer, precancerous lesions and non-cancerous lesions of the female reproductive system, anus and penis , especially for PDT of abnormal development of endometrium, cervix, vulva, vagina, anus and penis and HPV infection of uterus, cervix, vulva, vagina, anus and penis. The semi-solid compositions and pharmaceutical preparations comprise the active ingredient, namely 5-aminolevulinic acid (5-ALA) or a 5-ALA precursor or derivative, or a pharmaceutically acceptable salt thereof. The present invention also relates to a PDT method for treating cancerous, precancerous and noncancerous lesions of the female reproductive system, anus and penis, wherein said semisolid composition and pharmaceutical preparation are used. Background technique [0002] Photodynamic therapy (PDT) is a relatively new technique used to treat precance...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/195A61K9/06A61K47/10A61K47/14A61K47/44
CPCA61K9/0031A61K9/0034A61K9/06A61K31/195A61K31/221A61K41/0061A61K47/10A61K47/12A61K47/14A61K47/24A61K47/26A61P15/00A61P31/12A61P35/00
Inventor 格雷·斯滕斯鲁德
Owner PHOTOCURE
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