Single-dose packaged clotrimazole liquid composition

A single-dose, composition-based technology used in the medical and pharmaceutical packaging industry to address issues of lack of stability, loss of efficacy, etc.

Pending Publication Date: 2021-09-21
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The proposed lack of stability of these suspensions due to phase separation may be a problem during administration of the suspension to the ear cavity, as part of the active agent may remain in the syringe in solid form, resulting in a loss of efficacy

Method used

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  • Single-dose packaged clotrimazole liquid composition
  • Single-dose packaged clotrimazole liquid composition
  • Single-dose packaged clotrimazole liquid composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Example 1 - PEG solution (1.2% water content) of a single dose package

[0138] Formula 1 :

[0139] Element % (W / v) Gramps 1％ Polyethylene glycol 400 (PEG-400) Mandidity is 100%

[0140] Manufacturing process :

[0141] The single dose package of this embodiment is obtained in the BFS Equipment Rommelag BP321M. First, a solution of the active ingredient in PEG 400 was prepared at 40 ± 15 ° C. In order to sterilize the solution, two sterilized filters (polyvinylidene fluoride (PVDF) membrane filters, aperture of 0.22 μm) were used. The integrity of these filters was checked prior to use and dried at 70 ° C for at least 5 hours. On the other hand, the storage tank was sterilized with vapor and the residual water was removed after sterilization. The grade p-PEG solution was filtered through the first drying filter. The first volume filtering solution was discarded, and the filtered solution was introduced into the first storage tank after minimizi...

Embodiment 2

[0142] Example 2 - Single dose packaged gramps PEG solution (0.8% water content, oxygen content

[0143] Formula 1 :

[0144] Element % (W / v) Gramps 1％ Polyethylene glycol 400 (PEG-400) Mandidity is 100%

[0145] Manufacturing process :

[0146] As described in Example 1, the single dose package of Example 2 was prepared in Example 2, in addition to the fact that a nitrogen stream is used during seal secondary packaging (aluminum foil composite bag). Compared to total weight of the composition, the water content of the product (by Karl Fischer USP 41 (Method I, instrument Volumetric Karl Fischer TitRatorTler Toledo V20s) is 0.8%, and the total volume of gas content in the secondary package, Oxygen content in secondary packaging (through top aerodynamic analyzer Measurement) below 10% by volume.

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Abstract

It relates to a single-dose packaging unit which is a blow-fill-seal (BFS) container which comprises a sterile pharmaceutical or veterinary liquid composition which is a solution, wherein a) the composition comprises a therapeutically effective amount of clotrimazole or a pharmaceutically or veterinary acceptable salt thereof, together with one or more pharmaceutically or veterinary acceptable excipients or carriers, and b) the container has a volume from 0.05 to 8 mL, with the condition that the water content of the composition is equal to or lower than 4% by weight with respect to the total composition weight. It also relates to a secondary packaging comprising one or more single-dose packaging units.

Description

[0001] This application claims the rights of European Patent Application No. 19382120.4, filed on February 19, 2019. Technical field [0002] The invention belongs to the field of medical and pharmaceutical packaging industries. In particular, the present invention relates to a single dose-packaged liquid drug or veterinary composition comprising a gramazole or a salt thereof, and more particularly, the present invention relates to a gravor composition, which is placed in a single dose blowing Fill in the seal (BFS) container. Background technique [0003] Gramp 1 - [(2-chlorophenyl) diphenyl methyl] imidazole international non-patented drug name (INN), is the INNATIONAL NONPROPRIETARY; Inn. The CAS registration number of the gravy is 23593-75-1, and its chemical structure is shown as follows: [0004] [0005] Grampsazole showed broad-spectrum antifungal activity. Its action mechanism is based on the inhibition of biosynthesis of steroids (especially wheatone sterol) desired to...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/34A61K9/08A61K31/4174A61P31/10
CPCA61K9/0048A61K9/08A61K31/4174A61K47/34A61P31/10A61K47/10A61J1/1468
Inventor M·M·特拉兹·门多萨J·萨纳古斯汀·阿奎卢A·泰莱兹·莫利纳M·I·德尔加多·加安
Owner LAB SALVAT
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