Claims
- 1. A solid preparation for injection use which comprises an antimicrobially effective amount of compound A which is D-7-[.alpha.-(4-hydroxy-6-methylnicotinamido)-4-hydroxyphenylacetamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate and from 50 to 200 mg. per 1 gm. potency unit of D-7-[.alpha.-(4-hydroxy-6-methyl-nicotinamido)-4-hydroxyphenylacetamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate of a stabilizer selected from the group consisting of benzoic acid and sodium benzoate, and a suitable amount of a pharmaceutically acceptable pH-adjustable compound in an amount sufficient to adjust pH of an injectable aqueous solution to a range of 6 to 9 when said solid preparation is reconstituted as an injectable aqueous solution prior to the injection, formed by the steps of:
- (a) forming an aqueous solution of compound A, said stabilizer and said pH-adjustable compound; and
- (b) freeze-drying the aqueous solution to form said solid preparation.
- 2. The solid preparation according to claim 1, wherein the concentration of D-7-[.alpha.-(4-hydroxy-6-methylnicotinamido)-4-hydroxyphenylacetamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate in the aqueous solution to be freeze-dried is 10 w/v %-20 w/v %.
- 3. The solid preparation according to claim 1, wherein the stabilizer is sodium benzoate.
- 4. A process for producing an antimicrobial preparation of enhanced stability which comprises dissolving a microbially effective amount of D-7-[.alpha.-(4-hydroxy-6-methylnicotinamido)-4-hydroxyphenylamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate and from 50 to 200 mg. per 1 gm. potency unit of D-7-[.alpha.-(4-hydroxy-6-methyl-nicotinamido)-4-hydroxyphenylacetamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate of a stabilizer selected from the group consisting of benzoic acid and sodium benzoate in an aqueous injectable solution adjusting the pH value of the solution to a pH in the range of 6 to 9, sterilizing the solution by passing it through a bacterial filter and freeze-drying the solution.
- 5. The process according to claim 4, wherein the stabilizer is sodium benzoate.
- 6. The process according to claim 4, wherein the concentration of D-7-[.alpha.-(-hydroxy-6-methylnicotinamido)-4-hydroxyphenylacetamido]-3-(1-methyltetrazol-5-yl)thiomethyl-.DELTA..sup.3 -cephem-4-sodium carboxylate in the aqueous solution to be freeze-dried is 10 w/v %-20 w/v %.
Priority Claims (1)
Number |
Date |
Country |
Kind |
55-137939 |
Oct 1980 |
JPX |
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Parent Case Info
This application is a continuation of application Ser. No. 732,809, filed May 10, 1985, now abandoned, which in turn is a continuation of application Ser. No. 525,258, filed Aug. 22, 1983, now abandoned, which in turn is a continuation of application Ser. No. 305,710, filed Sept. 25, 1981, now abandoned.
US Referenced Citations (7)
Non-Patent Literature Citations (4)
Entry |
Remington Pharmaceutical Sciences, 16, p. 1367 (1980). |
Drugs of the Future, vol. 5(5), pp. 254-255 (1980). |
The Merck Index, 9th ed., pp. 142-143 and 1109 (1976). |
Pharmazie, 24, 155-157 (1969) W/Abstract [Ring Doc. Profile (Derwent Co.)]. |
Continuations (3)
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Number |
Date |
Country |
Parent |
732809 |
May 1985 |
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Parent |
525258 |
Aug 1983 |
|
Parent |
305710 |
Sep 1981 |
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