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Synergistically cooperative compositions useful for soft tissue augmentation, drug delivery and related fields

A technology of synergy and composition, applied in the directions of drug delivery, drug combination, medical preparations of inactive ingredients, etc., can solve the problems of high production cost, a large number of biopolymers, and unfavorable stability of biopolymers.

Pending Publication Date: 2021-03-30
ALTERGON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The target viscoelasticity can be obtained by appropriate manipulation of the parameters of the selected biopolymer (e.g. molecular weight, molecular weight distribution, solubility in solution, use of salts or derivatives, etc.); however, reaching the target viscoelastic curve may require extensive biopolymerization material, resulting in high production costs
Furthermore, a challenge for these products is maintaining the desired viscoelastic behavior over long periods of time, especially during manufacturing, which often involves subjecting biopolymer solutions to intensive sterilization processes at high temperatures and pressures (autoclaving): it is well known that These treatments are detrimental to biopolymer stability, leading to undesired viscoelastic changes, which are difficult to adjust at this late stage of fabrication

Method used

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  • Synergistically cooperative compositions useful for soft tissue augmentation, drug delivery and related fields
  • Synergistically cooperative compositions useful for soft tissue augmentation, drug delivery and related fields
  • Synergistically cooperative compositions useful for soft tissue augmentation, drug delivery and related fields

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0061] 1. Preparation and preparation

[0062] The following table shows the compositions of Formulation Examples 1 to 5.

[0063] Table 1. Composition of Formulation Examples 1 to 5

[0064]

[0065] HA = hyaluronic acid; FA = fatty acid; CD = cyclodextrin; VE = vitamin E

[0066] 1.1. Embodiment 1 (reference) and 2 (the present invention)

[0067] The solutions according to Examples 1 and 2 were obtained by the following steps:

[0068] Appropriate emulsifiers were weighed into appropriate containers and diluted in PBS.

[0069] Weigh FA and add to the previous solution.

[0070] HA and vitamin E (if present) according to the formulation examples were added to the previous mixture at room temperature.

[0071] Finally, dilute the previous mixture with PBS and keep stirring for at least 3 to 8 hours.

[0072] The product obtained from said procedure is homogeneous with one phase.

Embodiment 3

[0073] 1.2. Embodiment 3 (reference) and 4 (the present invention)

[0074] The solutions according to Examples 3 and 4 were obtained by the following steps:

[0075] CDs were weighed into appropriate containers and diluted in phosphate buffered saline (PBS).

[0076] HA and vitamin E (if present) according to the formulation examples were added to the previous solution at room temperature.

[0077] Finally, dilute the previous mixture with PBS and keep stirring for at least 3 to 8 hours.

[0078] The product obtained from said procedure is homogeneous with one phase.

Embodiment 5

[0079] 1.3. Embodiment 5 (reference)

[0080] The solution according to Example 5 was obtained by the following steps:

[0081] HA and vitamin E according to the formulation examples were added to PBS and kept stirring for at least 3 to 8 hours.

[0082] The product obtained from said procedure is homogeneous with one phase.

[0083] 2. Evaluation of viscoelasticity

[0084] Viscoelasticity measurements were performed by a strain-controlled rotational rheometer (Mars III, HAAKE rheometer, Waltham, MA USA) at 20°C and 37°C using parallel plate geometry. The frequency is 0.01Hz to 10Hz. In order to determine the linear viscoelastic response range of the material, the initial strain sweep test was carried out on the sample at an oscillation frequency of 1 Hz. The test was repeated at least three times on each sample.

[0085] Figure 1-4 The frequency dependence of the elastic modulus G' and the viscous modulus G", the so-called "mechanical spectrum", is reported in . Speci...

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Abstract

The present invention relates to compositions based on: (a) a glycosaminoglycan or mixtures thereof;(b) one or more tocopherols, tocotrienols and mixtures thereof; (c) a selected stabilizer. The composition is in solution form, with the above agents being present within specific concentration ranges, without being engaged in formal chemical binding with each other. The component (a) can be e.g. hyaluronic acid (HA) or a salt thereof; the component (b) can be a polyether clathratee.g. a cyclodextrin, or a combination of a fatty acid with an emulsifier; the component (c) can be one or more amongAlpha- tocopherols, Beta-tocopherols, Gamma-tocopherols, Delta-tocopherols; Alpha-tocotrienols, Beta-tocotrienols, Gamma-tocotrienols, Delta-tocotrienols; preferably the component (c) is vitamin E. In the present compositions, the above agents strongly cooperate to provide enhanced and more stable viscoelastic properties, resulting in a product with higher resistant to thermal treatments like e.g. heat-sterilization, autoclaving, etc. The present compositions, optionally loaded with pharmaceutically and / or cosmetically active agents, are advantageously used in medical or cosmetic methods.

Description

technical field [0001] The present invention relates to the field of products and compositions having viscoelasticity, optionally loaded with active ingredients as a drug delivery system, useful in the fields of medicine, surgery and dermoaesthetics, and methods for enhancing and stabilizing the viscoelasticity . Background technique [0002] Synovial joints are the most numerous joints, especially in the extremities. In these joints, bones are connected by a cavity filled with a viscous, elastic fluid called synovial fluid. Synovial fluid is responsible for the function and protection of joints. There are high concentrations of high molecular weight glycosaminoglycans such as hyaluronic acid and chondroitin sulfate in synovial fluid. Specifically, hyaluronic acid (HA) acts as a shock absorber and provides essential lubrication to joints, and it reduces friction on moving bones to reduce wear and tear. In inflammatory diseases such as osteoarthritis or rheumatoid arthrit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/36A61K47/40A61K47/69A61K31/196A61K31/728A61K47/22A61P29/00
CPCA61K31/728A61K47/22A61K47/36A61K47/40A61K47/6951A61P29/00A61K9/08A61K9/0019A61K31/355A61K31/724A61K2300/00A61K31/192A61K31/196A61K31/407A61K31/421A61K31/4365A61K31/4706A61K31/496A61K31/5415A61K31/60A61K31/616A61L27/26A61L2300/21A61L2300/216A61L2300/232A61L2300/236A61L2300/41
Inventor 阿孙塔·博尔扎奇耶洛毛里齐奥·帕柳卡尼古拉·索利曼多路易吉·尼古拉斯
Owner ALTERGON