Antiseptic Solution of Di(4-Chloro-Phenyldiguanido) Compound And Process Therefor
AssigneeCombino Pharm, S.L.
InventorsMarina Puigvert COLOMER, Sergio Lloret Perez
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Abstract
The present invention relates to a stable antiseptic solution comprising: a di(4-chlorophenyldiguanido) compound or a pharmaceutically acceptable salt thereof, wherein said di(4-chlorophenyldiguanido) compound or a pharmaceutically acceptable salt thereof is a compound of formula (I) or a pharmaceutically acceptable salt thereof. The invention further relates to a process for preparing said antiseptic solution.
Claims45
A stable antiseptic solution comprising a di(4-chlorophenyldiguanido) compound of formula (I) or a pharmaceutically acceptable salt thereof,
- one or more anionic dyes, and one or more solvents, wherein the one or more anionic dyes is present in an amount sufficient to stain a patient's skin or surgical field, and wherein the antiseptic solution is essentially free of cationic excipients.
A process for preparing a stable antiseptic solution comprising a di(4-chlorophenyldiguanido) compound of formula (I) or a pharmaceutically acceptable salt thereof,
- comprising:
- (i) dissolving one or more anionic dyes in one or more first solvents to provide an anionic dye solution, and
- (ii) adding the di(4-chlorophenyldiguanido) compound of formula (I) or a pharmaceutically acceptable salt thereof to the anionic dye solution of step (i).
A process for preparing a stable antiseptic solution comprising a di(4-chlorophenyldiguanido) compound of formula (I) or a pharmaceutically acceptable salt thereof,
- comprising:
- (i) dissolving one or more anionic dyes in one or more first solvents to provide an anionic dye solution,
- (ii) dissolving the di(4-chlorophenyldiguanido) compound of formula (I) or a pharmaceutically acceptable salt thereof in one or more second solvents to provide a solution of a compound of formula (I) or a pharmaceutically acceptable salt thereof, and
- (iii) combining the anionic dye solution and solution of a compound of formula (I) or a pharmaceutically acceptable salt thereof.
A process for preparing a stable antiseptic solution comprising di(4-chlorophenyldiguanido) compound of formula (I) digluconate:
- comprising:
- (i) dissolving one or more anionic dyes in one or more first solvents to provide an anionic dye solution,
- (ii) adding one or more lower alkanols to the anionic dye solution,
- (iii) dissolving the di(4-chlorophenyldiguanido) compound of formula (I) digluconate in one or more second solvents to provide a solution of di(4-chlorophenyldiguanido) compound of formula (I) digluconate,
- (iv) combining the anionic dye solution and the solution of step (iii) to provide a combined solution, and
- (v) adding one or more lower alkanols to the combined solution of step (iv).
A stable antiseptic solution comprising about 2% (w/v) of a pharmaceutically acceptable salt of a di(4-chlorophenyldiguanido) compound of formula (I):
- about 30% (v/v) of water, about 70% (v/v) of isopropanol, and about 0.2% (w/v) of an anionic dye.
Dependencies are inferred from the claim text.