Hydrophilic preservative used in a formulation is
Answers
Answer:
Propyleneglycol as a hydrophilic excipient is an excipient generally used as a co-solvent for increasing drug solubility in an aqueous solution type formulation and/or an emulsion formulation.
Formulation
Formulation No. Oil. Preservative
1. MCT 0.5% (w/v) phenol
2. MCT 1.5%benzylalcohol
3. MCT 0.5% m-cresol
4. MCT 0.5% chlorobutanol
Explanation:
Abstract
Disclosed herein is preferably a multi-dose type non-aqueous oily injectable formulation including; an active ingredient (drug) expressing therapeutic effects, which is dissolved, dispersed or suspended in a therapeutically effective amount, in oil. The disclosed non-aqueous oily injectable formulation may include; an oil-affinitive preservative, and a hydrophilic excipient non-phase separable from the oil-affinitive preservative when the excipient is mixed with the oil-affinitive preservative.
Example: Preservative efficacy in oil other than MCT
The present experiment was executed to identify whether a preservative system developed according to the present invention may be applied to oils other than MCT. Sesame oil and peanut oil, respectively, were mixed with propyleneglycol and phenol to prepare formulations, in turn forming SR-hGH suspensions, as described in Example 3. Preservative efficacy of each of the obtained suspensions was compared to formulations without preservatives. In this case, the kinds of oils used herein and contents of additives are shown in Table 17 below.
Table 17 Formulation containing other oil as a substitute for MCT
Formulation No. Oil Microfine particles Additive (%(w/v))
17 Sesame oil SR-hGH None
18 Sesame oil SR-hGH 0.75% propyleneglycol + 0.3% phenol
19 Peanut oil SR-hGH None
20 Peanut oil SR-hGH 0.75 propyleneglycol + 0.3% phenol
Table 18 Preservative efficacy of formulation containing other oil as a substitute for MCT (S. aureus)
Formulation No. Log Reduction
6 hours 24 hours 7 days 14 days
17 1.0 < 1.0 - -
18 3.6 3.9 - -
19 1.9 2.4 - -
20 3.1 4.2 - -
As shown in the above Table 18, it was confirmed that the preservative composed of phenol and propyleneglycol, which are mixed with MCT in previous example also exhibits excellent preservative efficacy in sesame oil and peanut oil, respectively, as non-aqueous solutions other than MCT.
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Propyleneglycol as a hydrophilic excipient is an excipient generally used as a co-solvent for increasing drug solubility in an aqueous solution type formulation and/or an emulsion formulation.
...
Formulation No. Oil Preservative
2 MCT 0.5% (w/v) phenol
3 MCT 1.5% benzyl alcohol
4 MCT 0.5% m-cresol
5 MCT 0.5% chlorobutanol
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