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Title:
PRODUCT COMPRISING HYDROLIZED COLLAGEN AND AT LEAST ONE AMORPHOUS MICRONIZED DRUG, PROCESS FOR THE PREPARATION THEREOF AND RELATED USES IN MEDICAL FIELD
Document Type and Number:
WIPO Patent Application WO/2017/094038
Kind Code:
A4
Abstract:
The present invention relates to a product consisting of a conglomerate of collagen, in the form of the partly hydrolyzed industrial derivative thereof called gelatine, and an amorphous micronized drug, characterized by a high bioavailability of the micronized active ingredient and a safety of use of the same deriving from the protective action of collagen against the harmful effects of contact with the active ingredient.

Inventors:
SILVESTRINI BRUNO (IT)
MOLLACE VINCENZO (IT)
Application Number:
PCT/IT2016/000284
Publication Date:
August 24, 2017
Filing Date:
December 02, 2016
Export Citation:
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Assignee:
S B M S R L (IT)
3M&F CONSULTING S R L S (IT)
International Classes:
A61K9/00; A61K9/06; A61K9/14; A61K9/48; A61K31/192; A61K31/573; A61K31/616; A61K47/42
Attorney, Agent or Firm:
IANNONE, Carlo Luigi (IT)
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Claims:
AMENDED CLAIMS

received by the International Bureau on 30 June 2017 (30.06.2017).

1) Product, or composition product, comprising or consisting of at least one amorphous micronized drug and partially hydrolyzed collagen, said product being obtainable through amorphization by co-grinding at least one crystalline micronized drug in powder mixture with partially hydrolyzed collagen.

2) Product according to claim 1 , wherein the ratio between said drug and partially hydrolyzed collagen ranges from 1 :1 to 1 :30 by weight, preferably from 1 :3 to 1:20.

3) Product according to anyone of claims 1-2, wherein said at least one drug has particle size smaller than 40 microns, preferably from 5 to 20 micron.

4) Product according to anyone of claims 1-2, wherein partially hydrolyzed collagen has Bloom degree from 50 to 300.

5) Product according to anyone of claims 1-2, wherein said at least one drug is chosen from the group consisting of solid crystalline nonsteroidal anti-inflammatory drugs, such as acetylsalicylic acid, ibuprofen and nimesulide, corticosteroid drugs such as dexamethasone, or antibiotics.

6) Pharmaceutical composition comprising or consisting of the product as defined in anyone of claims 1-5, as active principle, in association with one or more excipients and /or coadjuvant.

7) Pharmaceutical composition according to claim 6, said pharmaceutical composition further comprising a drug not co-ground with partially hydrolyzed collagen.

8) Pharmaceutical composition according to anyone of claims 6- 7, wherein said pharmaceutical composition has a form chosen among swallowable or orodispersible oral form, sublingual form, topical form for skin or mucosa, and inhalatory form.

9) Product as defined in anyone of claims 1-5 or pharmaceutical composition as defined in anyone of claims 6-8, for use in the medical field. 10) Process for the preparation of the product as defined in anyone of claims 1-5, said process comprising the steps a) preparing a powder mixture of at least one crystalline micronized drug and partially hydrolyzed collagen; b) grinding the mixture of step a) until amorphization of said at least one crystalline micronized drug is obtained.

11) Process according to claim 10, wherein the ratio between said at least one drug and partially hydrolyzed collagen ranges from 1:1 to 1:30 by weight, preferably from 1:3 to 1 :20.

12) Process according to anyone of claims 10-11 , wherein said at least one drug has particle size smaller than 40 microns, preferably from 5 to 20 microns.

13) Process according to anyone of claims 10-11 , wherein the partially hydrolyzed collagen has Bloom degree from 50 to 300.