CA2220871A1 - Peptide/protein suspending formulations - Google Patents

Peptide/protein suspending formulations

Info

Publication number
CA2220871A1
CA2220871A1 CA002220871A CA2220871A CA2220871A1 CA 2220871 A1 CA2220871 A1 CA 2220871A1 CA 002220871 A CA002220871 A CA 002220871A CA 2220871 A CA2220871 A CA 2220871A CA 2220871 A1 CA2220871 A1 CA 2220871A1
Authority
CA
Canada
Prior art keywords
formulation
beneficial agent
agent
suspension
molecular weight
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
Application number
CA002220871A
Other languages
French (fr)
Other versions
CA2220871C (en
Inventor
James B. Eckenhoff (Deceased)
Leslie A. Holladay
John Joseph Leonard Jr.
Iris K. M. Leung
Sally A. Tao
Judy A. Magruder
John P. Carr
Jeremy C. Wright
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Durect Corp
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2220871A1 publication Critical patent/CA2220871A1/en
Application granted granted Critical
Publication of CA2220871C publication Critical patent/CA2220871C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

Abstract

The present invention provides improved compositions for improving the chemical and physical stability of peptides and proteins.
The invention provides a liquid beneficial agent formulation containing a liquid suspension comprising at least 5 % by weight beneficial agent and having a viscosity and beneficial agent size which minimizes setting of the agent in suspension over the extended delivery period.

Claims (18)

1. A beneficial agent formulation for use in a device which delivers the formulation over an extended delivery period, the formulation comprising a suspension containing at least 5% by weight beneficial agent in the form of solid particles, the beneficial agent particle size being 0.3 to 50 microns and the suspension viscosity being sufficient to prevent settling of the agent in the suspension formulation over the extended delivery period.
2. The formulation of claim 1, wherein the particle size is between 1 to 10 microns.
3. The formulation of claim 1, wherein the viscosity is 100 to 100,000 poise at 37°C.
4. The formulation of claim 1, wherein the extended delivery period is at least about 1 month.
5. The formulation of claim 1, wherein the liquid suspension further comprises a low molecular weight polyol and a thickening agent.
6. The formulation of claim 5, wherein the polyol is polyethylene glycol having a molecular weight between 200 and 1000.
7. The formulation of claim 6, wherein the thickening agent comprises povidone.
8. The formulation of claim 5, wherein the polyol is polyethylene glycol having a molecular weight between 200 and 600.
9. The formulation of claim 8, wherein the thickening agent comprises povidone or hydroxypropyl cellulose.
10. The formulation of claim 1, wherein the beneficial agent is human .alpha.-interferon.
11. The formulation of claim 10, wherein the concentration of interferon is at least 1 x 109 IU.
12. The formulation of claim 1, wherein said beneficial agent is a water sensitive compound.
13. A beneficial agent delivery device containing the formulation of claim 1.
14. The beneficial agent delivery device of claim 13, wherein the device is adapted to be implanted within an animal.
15. A composition for sustained controlled delivery over an extended delivery period, the composition comprising:
(a) 0.5% to 70% by weight beneficial agent having a particle size of between 0.3 to 50 microns; and (b) a non-aqueous liquid suspension formulation characterized by a viscosity of between 100 to 100,000 poise at 37 ° C, the formulation further comprising polyethylene glycol with a molecular weight between 200 and 1000 and a thickening agent.
16. The composition according to claim 15, wherein the thickening agent comprises povidone or hydroxypropyl cellulose.
17. A beneficial agent delivery device containing the composition of claim 15.
18. The beneficial agent delivery device of claim 17, wherein the device is adapted to be implanted within an animal.
CA2220871A 1995-06-07 1996-05-22 Peptide/protein suspending formulations Expired - Fee Related CA2220871C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/475,238 1995-06-07
US08/475,238 US5904935A (en) 1995-06-07 1995-06-07 Peptide/protein suspending formulations
PCT/US1996/007377 WO1996040049A1 (en) 1995-06-07 1996-05-22 Peptide/protein suspended formulations

Publications (2)

Publication Number Publication Date
CA2220871A1 true CA2220871A1 (en) 1996-12-19
CA2220871C CA2220871C (en) 2011-02-08

Family

ID=23886776

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2220871A Expired - Fee Related CA2220871C (en) 1995-06-07 1996-05-22 Peptide/protein suspending formulations

Country Status (14)

Country Link
US (2) US5904935A (en)
EP (1) EP0831773B1 (en)
JP (2) JPH11506730A (en)
KR (1) KR100460653B1 (en)
CN (1) CN1138528C (en)
AT (1) ATE187062T1 (en)
AU (1) AU706318B2 (en)
CA (1) CA2220871C (en)
DE (1) DE69605417T2 (en)
DK (1) DK0831773T3 (en)
ES (1) ES2139360T3 (en)
FI (1) FI119464B (en)
NZ (1) NZ308843A (en)
WO (1) WO1996040049A1 (en)

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JPH11506730A (en) 1999-06-15
US5904935A (en) 1999-05-18
KR19990022486A (en) 1999-03-25
JP2009057389A (en) 2009-03-19
ATE187062T1 (en) 1999-12-15
CN1138528C (en) 2004-02-18
DE69605417D1 (en) 2000-01-05
DK0831773T3 (en) 2000-05-08
DE69605417T2 (en) 2000-03-23
FI974429A0 (en) 1997-12-05
NZ308843A (en) 2000-01-28
EP0831773A1 (en) 1998-04-01
WO1996040049A1 (en) 1996-12-19
AU5869496A (en) 1996-12-30
CN1187119A (en) 1998-07-08
FI974429A (en) 1997-12-05
KR100460653B1 (en) 2005-08-05
FI119464B (en) 2008-11-28
US5972370A (en) 1999-10-26
ES2139360T3 (en) 2000-02-01
AU706318B2 (en) 1999-06-17
EP0831773B1 (en) 1999-12-01
CA2220871C (en) 2011-02-08

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