Exams of vaginalia

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The European Pharmacopoeia (Pharmacopoea Europaea, Ph.Eur.) Prescribes various tests for vaginalia . The prepared preparations for vaginal use are examined according to the respective test specifications and their quality is assessed.

Uniformity of single-dose dosage forms

Each unit of a batch must have an active ingredient content that is within defined limits around the target value. This is the " uniformity of single-dose dosage forms " method (according to Ph. Eur. 2.9.40). According to the older methods "uniformity of the mass of single-dose dosage forms" (Ph. Eur. 2.9.5) and "uniformity of the content of single-dose dosage forms" (Ph. Eur. 2.9.6), the target value is not included.

Single-dose preparations for vaginal use must comply with the test for uniformity of single-dose dosage forms (Ph.Eur.2.9.40). This test, described in the European Pharmacopoeia (Pharmacopoeia Europaea, Ph.Eur.), Is used to determine the uniformity of the dosage of divided dosage forms such as vaginal tablets. The uniformity is defined in the Ph. Eur. As "the degree of uniformity of the amount of active ingredient in a certain number of units".

Uniformity of salary

The content checks ensure that the dosage of the drug is consistent. The respective content is determined using suitable analysis methods and the average content is determined from this. Solid, single-dose preparations for vaginal use with less than 2 mg or 2% active ingredient, based on the total mass, must comply with the test for " uniformity of content " (Ph. Eur. 2.9.6).

In the case of vaginal tablets, test A is carried out. 10 random samples are taken and the individual salary is evaluated. If each individual content is between 85% and 115% of the average content, the preparation corresponds to the test. However, if the individual content of at least two random samples is outside the average content of 85% - 115% or an individual content outside 75% - 125%, the preparation does not correspond to the test.

If the individual content of a random sample is outside the average content of 85% - 115%, but within 75% - 125%, the active ingredient content of 20 additional units is determined. The test corresponds to the preparation if no more than a single content of 30 tablets is outside the 85% - 115% limit and no random sample is outside the 75% - 125%.

In the case of vaginal suppositories and vaginal capsules, test B is carried out. For this, 10 random samples are taken and the individual salary is analyzed. The preparation corresponds to the test if at most an individual content is outside 85% - 115% and no random sample is outside the 75% - 125% limit of the average content. If more than 3 random samples are outside 85% - 115% or at least one outside 75% - 125% of the average content, the preparation does not correspond to the test. If two or three samples are outside 85% - 115% of the average salary, 20 additional units are analyzed. If a maximum of 3 of the 30 dosage forms are outside 85% - 115% or all are within the 75% - 125% limit of the average content, the preparation corresponds to the test.

Uniformity of mass

Solid, single-dose preparations for vaginal use must comply with the test for “uniformity of mass” (Ph. Eur. 2.9.5) (2). This test can be omitted if the “test for uniformity of content” is prescribed for all individual active substances.

According to the European Pharmacopoeia (Ph.Eur.), 20 arbitrary units are taken to check the "uniformity of the mass", weighed individually and the average mass is calculated. No more than two of the 20 units may deviate by more than 5% from the average mass and no unit by more than 10% from the average mass, otherwise the preparation does not correspond to the test.

Drug release

According to the European Pharmacopoeia, a suitable test for "release of active ingredients from solid dosage forms" (Ph. Eur. 2.9.42) or "release of active ingredients from solid lipophilic dosage forms" can be carried out in order to prove the required release of the active ingredient or active ingredients from solid, single-dose preparations for vaginal use. (Ph. Eur. 2.9.42). Vaginal suppositories, vaginal tablets and vaginal capsules with prolonged action are subject to testing.

If a test for “active substance release” is required, a test for “disintegration time” is not required.

Vaginal suppositories, vaginal tablets and vaginal capsules must be tested for the "disintegration time of suppositories and vaginal suppositories" (Ph. Eur. 2.9.2), unless they are intended for a modified release of active ingredients or for a prolonged local effect. The duration of the test for vaginal tablets and capsules is 30 minutes and for vaginal suppositories 60 minutes.

Tablets for the preparation of vaginal solutions or vaginal suspensions must disintegrate within 3 minutes if the test for the "disintegration time of tablets and capsules" (Ph. Eur. 2.9.1) is carried out with water at 15 to 25 ° C.

literature

  • Ph.Eur. 8th edition, Grundwerk 2014, pp. 1236–38 f. Preparations for vaginal use
  • Ph. Eur. 8th edition, 6th supplement: "2.9.40: Uniformity of single-dose dosage forms". Deutscher Apotheker Verlag, Stuttgart, ISBN 978-3-7692-6771-6 , pp. 7375 ff.
  • Voigt Pharmaceutical Technology - for studies and work. 11th edition. German pharmacist publisher.

Web links

Individual evidence

  1. ↑ a b c d e Ph.Eur. 8th edition, Grundwerk 2014, pp. 1236–38 f. Preparations for vaginal use
  2. ↑ a b c d e Ph. Eur. 8th edition, 6th supplement: "2.9.40: Uniformity of single-dose dosage forms". Deutscher Apotheker Verlag, Stuttgart, ISBN 978-3-7692-6771-6 , pp. 7375 ff.