Excipient preservatives and pharmaceutical compositions comprised thereof
Topically applicable pharmaceutical compositions contain at least one pharmaceutically active agent and an effective antimicrobial amount of a preservative excipient mixture and devoid of such amount of known preservative(s) as would otherwise itself impart an effective antimicrobial action thereto.
1. A topically applicable pharmaceutical composition which comprises at least one pharmaceutically active agent and an effective antimicrobial amount of a preservative excipient mixture, wherein said preservative excipient mixture comprises ethanol, water, thickener, from 0.5% to 1% by mass of ascorbyl palmitate, 5% by mass of propylene glycol and an ethanol/aqueous phase ratio ranging from 10% to 15%, wherein the thickener is selected from the group consisting of an acrylic acid compound, a cellulosic compound, and xanthan gum.
2. The topically applicable pharmaceutical composition as defined by claim 1 , formulated as an emulsion, cream, milk, ointment, impregnated pad, syndet, wipe, gel, spray, foam, lotion, stick, shampoo or washing base.
3. The topically applicable pharmaceutical composition as defined by claim 1 , formulated as an aqueous emulsion or aqueous lotion.
4. The topically applicable pharmaceutical composition as defined by claim 1 , wholly devoid of such known preservative(s).
5. The topically applicable pharmaceutical composition as defined by claim 1 , said preservative excipient mixture further comprising a humectant, an antioxidant, a surfactant, and/or a chelating.
6. The topically applicable pharmaceutical composition as defined by claim 5 , comprising a humectant selected from the group consisting of glycerol, glycerine, and polyethylene glycol.
7. The topically applicable pharmaceutical composition as defined by claim 5 , comprising an antioxidant selected from the group consisting of an ascorbic acid compound, a citric acid compound, a tartaric acid compound, a lactate, a tocopherol, butylhydroxyanisole, butylhydroxytoluene, tertiary butylhydroquinone and propyl gallate.
8. The topically applicable pharmaceutical composition as defined by claim 5 , comprising EDTA.
9. The topically applicable pharmaceutical composition as defined by claim 1 , further comprising an antioxidant, a humectant, water and an ethanol/aqueous phase ratio ranging from 10% to 15%.
10. The topically applicable pharmaceutical composition as defined by claim 1 , comprising less than 0.8% of a paraben.
11. The topically applicable pharmaceutical composition as defined by claim 10 , comprising less than 0.4% of propyiparaben.
12. The topically applicable pharmaceutical composition as defined by claim 1 , further comprising up to 1.8% by mass of at least one preservative selected from the group consisting of a formaldehyde-generating agent, a thiazine compound, a chlorinated compound, a phenolic compound, an alcoholic compound, bronopol, phenoxyethanol, a chloroxylenol, an acid compound, and/or benzalkonium chloride.
13. A composition of matter comprising a preservative excipient mixture, wherein the preservative excipient mixture comprises ethanol, water, thickener, from 0.5% to 1% by mass of ascorbyl palmitate, 5% by mass of propylene glycol and an ethanol laqueous phase ratio ranging from 10% to 15% wherein the thickener is selected from the group consisting of an acrylic acid compound, a cellulosic compound, and xanthan gum.
14. The composition as defined in claim 13 , wherein the composition further comprises up to 1.8% by mass of at least one preservative selected from the group consisting of a formaldehyde-generating agent, a thiazine compound, a chlorinated compound, a phenolic compound, an alcoholic compound, bronopol, phenoxvethanol, a chloroxylenol an acid compound, and/or benzalkonium chloride.
15. The topically applicable pharmaceutical composition as defined by claim 12 , wherein the formaldehyde-generating agent is imidazolidinylurea or diazolidinylurea.
16. The topically applicable pharmaceutical composition as defined by claim 12 , wherein the thiazine compound is methylchloroisothiazolinone (MCI).
17. The topically applicable pharmaceutical composition as defined by claim 12 , wherein the chlorinated compound is chlorhexidine.
18. The topically applicable pharmaceutical composition as defined by claim 12 , wherein the phenolic compound is paraben.
19. The topically applicable pharmaceutical composition as defined by claim 12 , wherein the acid compound is sorbic acid or benzoic acid.
20. A topically applicable pharmaceutical composition which comprises at least one pharmaceutically active agent and an effective antimicrobial amount of a preservative excipient mixture, wherein said preservative excipient mixture comprises ethanol, water, EDTA, from 0.5% to 1% by mass of ascorbyl palmitate, 5% by mass of propylene glycol and an ethanol aqueous phase ratio ranging from 10% to 15%.