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Polyquaternium-1
Product Introduction
Polyquaternium-1 is a type of Excipients which play a crucial role in the pharmaceutical industry as an essential category of active pharmaceutical ingredients (APIs). Polyquaternium-1 though not intended to have therapeutic effects themselves, are vital components that assist in formulating and manufacturing drugs.
Polyquaternium-1 is also called Polidronium chloride. It is amber to dark brown solid or solution, fairly hygroscopic; bland in taste and nonirritating. Have a large solubility in water, insoluble in ethanol, acetone or ethyl ether. Polyquaternium-1 is no obvious stimulation to the skin, not skin sensitization agent and revulsant, has good antibacterial properties; Polyquaternium-1 can be used as antiseptic for eye-drops as a kind of Ophthalmic preservatives
Polyquaternium-1 (Polidronium chloride) is a polycationic ophthalmic preservative. Polyquaternium-1 can inhibit growth of microbial contaminants in multi-dose bottles of topical medications. Polyquaternium-1 is a cationic polymer prepared by the controlled polymerization of dimethylamine and bis-dichlorobutene, end capped with tris-b-Hydroxyethylamine.
Polyquaternium-1 is an antimicrobial preservative, with higher antimicrobial effects and lower ocular irritation.used as bactericide in eye drops,soft lenses product and other ophalmic care products formulation.In skin care formulations,it can help to avoid or reduce the allergy and infection possibility.
Key Technical Parameters
Solid form |
Liquid form |
|
|
Appearance |
Amber to dark brown solid |
Amber to brown liquid |
|
Odor |
Without Stimulation |
Without Stimulation |
Water solubility |
Full Soluble |
Full Soluble |
|
Free Amine |
＜5.0% |
＜2.0% |
|
pH |
6.0~9.0 |
5.0~9.0 |
|
Chloride |
20.0~30.0% |
20.0~30.0% |
|
Internal standard content |
≥95.0% |
≥33.0% |
|
Total Number of Aerobic Microbial Count(TAMC) cfu/g |
＜10³ cfu/g |
＜10³ cfu/g |
|
Total Yeasts and Molds Count(TYMC) cfu/g |
＜10² cfu/g |
＜10² cfu/g |
Polyquaternium-1 is found in contact lens solutions and artificial tear formulations. PQ-1 is a quaternary ammonium compound similar to Benzalkonium chloride (BAK). Unlike BAK it is primary hydrophilic and much larger in size, about 27 times larger than BAK. Both its large size and lack of hydrophobic region may prevent it from entering mammalian cells, theoretically leading to less cytotoxicity and ocular surface disease compared to BAK.
Benzalkonium chloride (BAK)—used in approximately 70% of ophthalmic formulations—is well known to cause cytotoxic damage to conjunctival and corneal epithelial cells, resulting in signs and symptoms of ocular surface disease (OSD) including ocular surface staining, increased tear break-up time, and higher OSD symptom scores.
As a viable alternative Ophthalmic preservative of Benzalkonium chloride (BAK), Polyquaternium-1 has been used in contact lens solutions, artificial tear and other eye care formulations.
Applications
● Ophthalmic preservatives
● Antimicrobial preservative
Advantages
● Hydrophilic
● Much large in size
● Leads to less cytotoxicity and ocular surface disease
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