Intravaginal clindamycin ovule composition

A technology of clindamycin and drug clindamycin, applied in the directions of suppository delivery, pharmaceutical formulation, oil/fat/wax inactive ingredients, etc., can solve the problem of inconvenience of vaginal cream

Inactive Publication Date: 2002-07-24
PHARMACIA & UPJOHN CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, application of vaginal creams was considered inconvenient even for 3 days of treatment

Method used

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  • Intravaginal clindamycin ovule composition
  • Intravaginal clindamycin ovule composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Preparation of suppository

[0040] The following method was used to prepare a batch of 11,200 suppositories.

[0041] 1. In the preparation tank, 29kg WITEPSOL H-32 stearin NF matrix is ​​heated to 40±2℃ to melt. During the whole preparation process, the temperature of melting the suppository base was maintained at 40±2°C.

[0042] 2. Using a preheated filter, transfer 26.614 kg of molten matrix to a second preparation vessel equipped with a homogenizing mixer.

[0043] 3. Add 1.386 g of clindamycin phosphate equivalent to 1.12 kg of clindamycin free alkali into the above tank, mix and homogenize them to obtain a uniform dispersion.

[0044] 4. Transfer the drug dispersion to the jacketed tank and transport it to the forming / filling / sealing suppository machine.

[0045] 5. Maintain mixing and maintain the temperature at 40±2°C. Use an automatic forming / filling / seal machine to shape the drug dispersion into a 2.5g suppository.

Embodiment 2X

[0046] Example 2 X-ray diffraction detection

[0047] The Siemans D-5000 x-ray diffractometer was used to determine the polymorphic transformation state of the suppository. Scrape a sufficient amount of material to fill the sample pan of the diffractometer from the suppository, and then carefully fill it into the pan to ensure a flat surface. Pass the copper K-L with a nickel filter at a wavelength of 1.5406 3 Ray operation instrument. The instrument parameters are as follows: 45KV voltage, 40mA current, 0.2mm detector hole. Scan the sample at an angle of 3-40° 2θ at 2° 2θ / min. Figure 1 shows a typical diffraction pattern of a polymorphic phase transition sample from α to α'to β.

Embodiment 3

[0048] Example 3 Flow point determination

[0049] The flow point of the suppository was measured in the following way: A polarizing microscope equipped with a 20×pol long working distance objective lens was used in combination with a Mettler FP82 hot stage. Use a razor blade to obtain a small amount of suppository, place it on a pre-cleaned glass slide, and cover it with a cover glass. Use a light press to cover the cover glass to spread the sample evenly, and place the glass slide in the hot stage furnace. The sample is then heated in the range of 25-40°C at a rate of 2°C / min. Use a camera to observe the heating process, and use a synchronized screen digital temperature display and record. The pour point is defined as the temperature at which rapid flow of the sample occurs.

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Abstract

A highly storage-stable composition for vaginal administration of clindamycin is disclosed which is useful for the treatment of bacterial vaginosis. The composition is a vaginal suppository containing an antimicrobially effective amount of clindamycin dispersed in a Hard Fat NF suppository base. Hard Fat NF suppository bases provide a clindamycin product having long term storage stability while providing efficacy against bacterial vaginosis which is equivalent to clindamycin vaginal creams.

Description

[0001] Cross reference for related applications Background of the invention [0002] The present invention relates to the treatment of bacterial vaginosis (BV). The exact etiology of BV is currently unknown, although it appears to be the result of overgrowth of organisms in the vaginal flora. Usually even in mild cases, BV is painful for the patient because of the bad smell and discharge of the vagina. In addition, it is related to several urogenital diseases in epidemiology. The standard treatment for BV is Clindamycin Vaginal Cream (CVC) 100 mg daily for 7 days. It has recently been discovered that a 3-day treatment with CVC is as effective as a 7-day treatment. However, even for 3 days of treatment, the application of vaginal cream is considered inconvenient. Vaginal suppositories containing clindamycin will provide patients with another more convenient dosage form. Therefore, a vaginal suppository was developed that is at least equivalent to CVC...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/7056A61K47/44A61P31/04
CPCA61K31/7056A61K9/02A61P31/04
Inventor L·E·佩纳P·B·鲍曼R·S·乔C·V·佩歇克
Owner PHARMACIA & UPJOHN CO
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