CA2210996A1 - Liquid formulations for proteinic pharmaceuticals - Google Patents
Liquid formulations for proteinic pharmaceuticalsInfo
- Publication number
- CA2210996A1 CA2210996A1 CA002210996A CA2210996A CA2210996A1 CA 2210996 A1 CA2210996 A1 CA 2210996A1 CA 002210996 A CA002210996 A CA 002210996A CA 2210996 A CA2210996 A CA 2210996A CA 2210996 A1 CA2210996 A1 CA 2210996A1
- Authority
- CA
- Canada
- Prior art keywords
- sodium
- polyoxyethylene
- enhancing compounds
- absorption enhancing
- deoxycholate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
A liquid pharmaceutical agent formulation suitable for oral or nasal delivery comprises a proteinic pharmaceutical agent, water and at least two absorption enhancing compounds. The absorption enhancing compounds are selected from sodium salicylate, sodium lauryl sulphate, disodium ethylenediaminetetraacetic acid (disodium EDTA), oleic acid, linoleic acid, monoolein, lecithin, lysolecithin, deoxycholate, sodium deoxycholate, chenodeoxycholate, taurodeoxycholate, glycochenodeoxycholate, polyoxyethylene X-lauryl ether wherein X is from 9 to 20, sodium tauro-24, 25-dihydrofusidate, polyoxyethylene ether, polyoxyethylene sorbitan esters, p-t-octylphenoxypolyoxyethylene, N-lauryl-.beta.-D-maltopyranoside, 1-dodecylazacycloheptane-2-azone and phospholipids, wherein the amount of each of the absorption enhancing compounds is present in a concentration of from 1 to 10 wt./wt.% of the total formulation. Preferably each of the absorption enhancing compounds is present in a concentration of from 1.5 to 3.5 wt./wt.% The formulation is particulary adapted to oral delivery of insulin. A preferred insulin formulation contains about 2 wt.% each of chenodeoxycholate, deoxycholate and polyoxyethylene 9-lauryl ether absorption enhancers, an inorganic salt, e.g. sodium chloride, a protective polymer, e.g.
geletin, a protease inhibitor, e.g. bacitracin, and optionally an antioxidant, e.g. tocopherol.
geletin, a protease inhibitor, e.g. bacitracin, and optionally an antioxidant, e.g. tocopherol.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/442,358 | 1995-05-16 | ||
US08/442,358 US5653987A (en) | 1995-05-16 | 1995-05-16 | Liquid formulations for proteinic pharmaceuticals |
PCT/CA1996/000305 WO1996036352A1 (en) | 1995-05-16 | 1996-05-16 | Liquid formulations for proteinic pharmaceuticals comprising at least 2 absorption enhancers |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2210996A1 true CA2210996A1 (en) | 1996-11-21 |
CA2210996C CA2210996C (en) | 2001-04-03 |
Family
ID=23756510
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002210996A Expired - Fee Related CA2210996C (en) | 1995-05-16 | 1996-05-16 | Liquid formulations for proteinic pharmaceuticals |
Country Status (5)
Country | Link |
---|---|
US (1) | US5653987A (en) |
EP (1) | EP0813421A1 (en) |
AU (1) | AU5642396A (en) |
CA (1) | CA2210996C (en) |
WO (1) | WO1996036352A1 (en) |
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NZ222907A (en) * | 1986-12-16 | 1990-08-28 | Novo Industri As | Preparation for intranasal administration containing a phospholipid absorption enhancing system |
US4789660A (en) * | 1987-09-10 | 1988-12-06 | American Home Products Corporation | Insulin administration using methyl and propyl paraben |
AT392906B (en) * | 1987-10-08 | 1991-07-10 | Hoffmann La Roche | Pharmaceutical products for oral administration |
GB9012663D0 (en) * | 1990-06-07 | 1990-08-01 | Erba Carlo Spa | Galenic formulations containing cyclodextrins |
US5206219A (en) * | 1991-11-25 | 1993-04-27 | Applied Analytical Industries, Inc. | Oral compositions of proteinaceous medicaments |
US5482706A (en) * | 1992-04-17 | 1996-01-09 | Takeda Chemical Industries, Ltd. | Transmucosal therapeutic composition |
US5346701A (en) * | 1993-02-22 | 1994-09-13 | Theratech, Inc. | Transmucosal delivery of macromolecular drugs |
US5447729A (en) * | 1994-04-07 | 1995-09-05 | Pharmavene, Inc. | Multilamellar drug delivery systems |
-
1995
- 1995-05-16 US US08/442,358 patent/US5653987A/en not_active Expired - Lifetime
-
1996
- 1996-05-16 WO PCT/CA1996/000305 patent/WO1996036352A1/en not_active Application Discontinuation
- 1996-05-16 AU AU56423/96A patent/AU5642396A/en not_active Abandoned
- 1996-05-16 EP EP96913411A patent/EP0813421A1/en not_active Ceased
- 1996-05-16 CA CA002210996A patent/CA2210996C/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
CA2210996C (en) | 2001-04-03 |
EP0813421A1 (en) | 1997-12-29 |
AU5642396A (en) | 1996-11-29 |
WO1996036352A1 (en) | 1996-11-21 |
US5653987A (en) | 1997-08-05 |
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