Patent US1561322A successfully refreshed from Google Patents.
Patent US2962761A successfully refreshed from Google Patents.
Patent US5130255A successfully refreshed from Google Patents.
US5130255A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process for preparing storage stable pharmaceuticals
Assignee: Genentech Inc
•
Filing: 1990-12-13
•
Granted: 1992-07-14
•
Expires: 2010-12-13
Abstract
Abstract Container systems for stable storage of pharmaceutical compounds are disclosed. The container systems prevent the formation of adducts between pharmaceutical compounds and aldehydes during storage of these compounds in containers sealed with elastomeric stoppers that leach aldehydes. Methods for determining the presence of these adducts are also disclosed.
Inventors
- 👤 John E. Battersby
- 👤 William S. Hancock
- 👤 Virgil B. Lawlis, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 12:05
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/68; Y; Y10; Y10T; Y10T436/00; Y10T436/12; Y10T436/20; Y10T436/200833
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
70 words
A method comprising: (a) contacting a protein with an aldehyde; (b) analyzing the protein for the presence of an aldehyde adduct; and (c) if an adduct is determined to be present in step (b), then disposing and storing a pharmaceutical preparation of said protein free of adduct in a container sealed with an elastomeric stopper under conditions such that the protein does not react with aldehyde emitted by the stopper.
Claim 2
Independent Claim
70 words
A method comprising: (a) contacting a protein with an aldehyde; (b) analyzing the protein for the presence of an aldehyde adduct; and (c) if an adduct is determined to be present in step (b), then disposing and storing a pharmaceutical preparation of said protein free of adduct in a container sealed with an elastomeric stopper under conditions such that the protein does not react with aldehyde emitted by the stopper.
Claim 3
Dependent Claim
13 words
The method of claim 1 wherein the protein is in a lyophilized state.
Claim 4
Dependent Claim
13 words
The method of claim 1 wherein the aldehyde is in the gaseous state.
Claim 5
Dependent Claim
21 words
The method of claim 1 wherein the protein is in a lyophilized state and the aldehyde is in a gaseous state.
Claim 6
Dependent Claim
10 words
The method of claim 1 wherein the aldehyde is acetaldehyde.
Claim 7
Dependent Claim
25 words
The method of claim 1 wherein the conditions include interposing a barrier for preventing the diffusion of gaseous aldehydes from the stopper to the protein.
Claim 8
Dependent Claim
16 words
The method of claim 1 wherein said conditions include combining the protein with an aldehyde scavenger.
Claim 9
Dependent Claim
11 words
The method of claim 7 wherein the aldehyde scavenger is methioninamide.
Claim 10
Dependent Claim
20 words
The method of claim 8 wherein the protein has an amino-terminal methionyl and is a product of recombinant cell culture.
Claim 11
Dependent Claim
15 words
The method of claim 9 wherein the protein is human growth hormone or gamma interferon.
Claim 12
Dependent Claim
17 words
The method of claim 1 wherein the conditions include employing a stopper that does not emit acetaldehyde.
Claim 13
Dependent Claim
19 words
The method of claim 1 wherein the pharmaceutical preparation is more than 99 percent pure by weight of protein.
Claim 14
Dependent Claim
10 words
The method of claim 12 wherein the protein is sterile.
Claim 15
Dependent Claim
18 words
The method of claim 1 wherein any aldehyde adduct of step (b) is analyzed by ion exchange chromatography.
Claim 16
Dependent Claim
20 words
The method of claim 1 wherein any aldehyde adduct of step (b) is analyzed by reverse high performance liquid chromatography.
Claim 17
Independent Claim
69 words
A method comprising: (a) contacting a pharmaceutical with an aldehyde; (b) analyzing the pharmaceutical for the presence of an aldehyde adduct; and (c) if an adduct is determined to be present in step (b), then disposing and storing a preparation of said pharmaceutical free of adduct in a container sealed with an elastomeric stopper under conditions such that the pharmaceutical does not react with aldehyde emitted by the stopper.
Claim 18
Independent Claim
69 words
A method comprising: (a) contacting a pharmaceutical with an aldehyde; (b) analyzing the pharmaceutical for the presence of an aldehyde adduct; and (c) if an adduct is determined to be present in step (b), then disposing and storing a preparation of said pharmaceutical free of adduct in a container sealed with an elastomeric stopper under conditions such that the pharmaceutical does not react with aldehyde emitted by the stopper.
Claim 19
Dependent Claim
14 words
The method of claim 16 wherein the pharmaceutical contains at least one amine group.
Claim 20
Dependent Claim
18 words
The method of claim 17 wherein the pharmaceutical is stored under conditions whereby the amine group is protonated.
References Cited (Backward Citations)
US2652182A
Cited
US2649090A
Cited
US2698272A
Cited
US3198368A
Cited
US3313439A
Cited
US3424329A
Cited
US3552591A
Cited
US4105701A
Cited
US4397903A
Cited
US4413070A
Cited
US4414309A
Cited
US4713346A
Cited
US4691034A
Cited
WO1988009323A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-07-14 | 1996-01-13 | 1996-07-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-07-14 | 2000-01-13 | 2000-07-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-07-14 | 2004-01-13 | 2004-07-14 | $7700.00 | Window Closed / Lapsed |