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Composition and method for treating hpv

A composition and drug technology, applied in the field of treatment of viral infections, can solve the problems of activity decline and low stability of cidofovir, and achieve the effects of good stability and elimination of the risk of degradation

Inactive Publication Date: 2014-06-25
FEMALON S P R L +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability of cidofovir in creams is low and, therefore, its activity decays quickly
Furthermore, the preparation of the film includes a heating step which may create a risk of heat-mediated degradation of cidofovir

Method used

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  • Composition and method for treating hpv
  • Composition and method for treating hpv
  • Composition and method for treating hpv

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Embodiment 1: freeze-drying condition

[0124] Lyophilization of the aqueous composition comprising a bioadhesive polymer, and optionally a plasticizer and / or cidofovir to obtain a porous extensible matrix is ​​carried out according to the following protocol.

[0125] The polymer was dispersed in distilled water with slow stirring until completely homogeneous. Optionally, the dispersion obtained is stirred again after addition of the plasticizer until completely homogeneous. Disperse cidofovir and add 2M NaOH stock solution to reach pH7. The obtained mixture was transferred to a crystallizer and lyophilized. The freeze-drying conditions are as follows:

[0126] freezing

[0127] stage

temperature(°C)

time (h)

pressure (bar)

1

-35 (-30 to -35)

3.0 (2 to 4)

surroundings

2

-35 (-30 to -35)

0.5 (0.4 to 0.6)

surroundings

[0128] primary drying

[0129] stage

temperature(°C)

time (h) ...

Embodiment 2

[0132] Example 2: Components of the lyophilized composition

[0133] The following components and mixtures were evaluated for their ability to form the desired "sponge" structure after lyophilization.

[0134] Bioadhesive polymers:

[0135] -Hydroxypropylmethylcellulose (HPMC)

[0136] HPMC E5: Viscosity: 5mPa.s (=5cp) (2% aqueous solution)

[0137] HPMC E15: Viscosity: 12-18mPa.s (2% aqueous solution)

[0138] HPMC4000: Viscosity: 4000-5600mPa.s (2% aqueous solution)

[0139] HPMC K15: Viscosity: 11250-21000mPa.s (2% aqueous solution)

[0140] - Sodium Carboxymethyl Cellulose (NaCMC)

[0141] -Hydroxyethylcellulose (HEC)

[0142] HEC Natrosol250HX: Viscosity: 1500-2500mPa.s (1% aqueous solution)

[0143] HEC Natrosol250HHX: Viscosity: 3500-5500mPa.s (1% aqueous solution)

[0144] HEC Natrosol250M: Viscosity: 4500-6500mPa.s (2% aqueous solution)

[0145] HEC H4000: Viscosity: 4500-6500mPa.s (2% aqueous solution)

[0146] -Carbomer (Carbomer) 974P

[0147] -Hydroxypr...

Embodiment 3

[0155] Example 3: Evaluation of different lyophilized placebo compositions

[0156] Components were tested at different conditions and concentrations to assess the desired properties of the lyophilizate. A desired characteristic is a spongy texture that is easily spreadable when dry and capable of rehydrating easily and / or quickly to a gel of moderate viscosity (ie, not too liquid-like and not too viscous).

[0157] The following conditions were kept constant for easy comparison: crystallizer diameter (4 cm), the amount of water used to disperse the components (add 6 g (ad6 g), meaning that water was added to the composition until 6 g of the final composition before lyophilization), and Freeze drying cycle.

[0158] The placebo lyophilisate (ie without cidofovir) was evaluated first. Table 1 lists the tested concentrations of polymers and plasticizers.

[0159] Table 1

[0160] polymer

mg / cm 2

plasticizer

mg / cm 2

Remark

[0161] ...

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Abstract

The present invention relates to lyophilized compositions comprising cidofovir, hydroxypropyl methylcellulose (HPMC) or hydroxyethylcellulose (HEC) and optionally a plasticizer. In particular, the present invention relates to such compositions which form a sheet-shaped porous solid matrix. The invention also relates to methods for producing such compositions. The invention further relates to such compositions for use in treating human papillomavirus (HPV) infections and HPV-associated malignancies, in particular HPV lesions and cervical cancer.

Description

technical field [0001] The present invention relates to the treatment of viral infections. In particular, the invention relates to agents for the treatment of human papillomavirus (HPV) infection and associated malignancies. The present invention particularly relates to solid dosage forms for general drug delivery, topical application or mucosal delivery. Background technique [0002] DNA viruses such as herpes, pox, papillomavirus, adenovirus, smallpox virus, etc. can cause many different infectious diseases in humans. As an example, human papillomavirus (HPV) is a member of the Papillomaviridae family of non-enveloped DNA viruses that infect humans. Like all papillomaviruses, HPV is strictly epitheliophilic and only establishes productive infection in stratified epithelium of the skin or mucous membranes. Most of the nearly 200 known types of HPV cause no symptoms in most people, some types can cause warts, and others can cause a variety of cancers, most notably cervica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/19A61K9/70A61K31/675A61K47/38
CPCA61K31/675A61K9/006A61K9/19A61K9/0014A61K47/38A61K9/06A61K9/0034A61K9/7007A61P31/12A61P31/20A61P31/22A61P35/00
Inventor 马里耶·皮耶特布里吉特·埃夫拉尔伊莎贝尔·科亚
Owner FEMALON S P R L
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