Vaginalium
A Vaginalium is a solid, semisolid or liquid preparation in the vagina ( vagina should exercise usually a local effect).
Distinctions
In the monograph "Preparations for vaginal use", the European Pharmacopoeia differentiates between the following preparations:
- Vaginal suppositories
- Vaginal tablets
- Vaginal capsules
- Vaginal solutions, emulsions, suspensions
- Tablets for making vaginal solutions and suspensions
- Semi-solid preparations for vaginal use
- Vaginal foams
- Vaginal tampons
In addition, since 2001 there have also been vaginal drug release systems, one of which is the vaginal ring . These active ingredient release systems are characterized by a uniform release of the active ingredient over days.
Suppositories, globules, ovules
Vaginal suppositories are solid, single-dose preparations. Shape, volume and consistency are adapted to vaginal application. The active ingredient is dissolved or dispersed in a suitable base material. Most often, a water-soluble hydrogel of elastic nature composed of gelatin , glycerol and water is used. Other suitable bases include hard fat , macrogol and cocoa butter . According to the Pharmacopoeia , the disintegration time of vaginal suppositories must be checked according to monograph 2.9.2. The suppositories should disintegrate within 60 minutes.
Tablets
According to the European Pharmacopoeia, vaginal tablets are solid, single-dose preparations that are either not coated or coated with a thin polymer film. They are introduced with the help of an enclosed applicator. According to the Pharmacopoeia, vaginal tablets are tested for disintegration time according to monograph 2.9.2. They have to disintegrate within 30 minutes.
Uncoated tablets and film-coated tablets can be used to make vaginal solutions or suspensions. The tablets are single-dose and are dissolved or dispersed in water before use. A wide variety of auxiliaries can be used for this purpose. In addition, auxiliaries can be used to prevent the particles from aggregating. In the case of tablets for the production of vaginal solutions and vaginal suspensions, the disintegration time is checked according to Pharmacopoeia monograph 2.9.2. These must be less than 3 minutes in water at a temperature of 15 to 20 ° C.
Capsules
Vaginal capsules are usually soft capsules that are slightly larger than soft capsules for oral use. They usually consist of approx. 67% gelatine , 24% plasticizers, 7–8% water and 0.5–2% dyes or pigments. Titanium dioxide, for example, is suitable as the white pigment, and iron oxides are suitable as color pigments. Chlorophyll can be used as a coloring agent. Glycerol or sorbitol are often used as plasticizers. They represent solid, single-dose medicinal preparations. The vaginal capsules are z. B. used to restore and maintain the natural vaginal flora. The capsule is egg-shaped and has a smooth surface, which is intended to facilitate insertion. Overall, the capsule should have a uniform appearance. The capsules can also have a prolonged local effect. According to the Pharmacopoeia, when manufacturing these, it is important to carry out a suitable test with regard to the release of the active substance or substances. In addition, the vaginal capsules must comply with the test for disintegration time according to monograph 2.9.2, unless they are intended to achieve a modified effect or a prolonged effect. According to the regulations, the vaginal capsules must have disintegrated after 30 minutes.
Solutions, emulsions, suspensions
Vaginal solutions, vaginal suspensions and vaginal emulsions are liquid preparations. They are intended to have a local effect, are used for rinsing or for diagnostic purposes. Auxiliaries such as viscosity enhancers, solubility improvers, preservatives or others can be added to the preparations during production, but these must neither impair the pharmacological effect nor cause local irritation. It is important that vaginal emulsions, if they are phase separated, can be reversed by shaking them. In the case of suspensions, this also applies to any sediment that may occur. A homogeneous preparation must always be formed in order to ensure that the exact dose is taken. The preparation is used for vaginal infections.
Semi-solid preparations
The European Pharmacopoeia summarizes vaginal ointments, vaginal gels and vaginal creams as semi-solid preparations for vaginal use. These preparations are always provided with an applicator, which is intended to facilitate application in the vagina. Vaginal creams and ointments are often used to treat vaginal mycoses, while vaginal gels are often used to treat vaginal dryness.
Foams
The European Pharmacopoeia describes vaginal foams as preparations in which a large volume of gas is dispersed in a liquid. Such preparations contain surface-active substances that cause foam formation.
Vaginal foams have the advantage that they spread well and can therefore wet a large surface. They are often used as a contraceptive and have a spermicidal effect. The foam must be inserted deep into the vagina several minutes before coitus. A supplied applicator is used for this. However, it must be noted that the effectiveness of such a contraceptive as the sole contraceptive method is not great.
According to the Pharmacopoeia, the relative foam density and the expansion time are suggested for testing the foams. With the relative foam density, the container is set to a constant temperature at approx. 25 ° C for at least 24 hours. The vessel must not be heated during the test either. Then the applicator is connected to a 70 to 100 mm long tube with a diameter of one millimeter. The container is then shaken to create a homogeneous phase. Then 5-10 ml of foam are dispensed, but are discarded. Then foam is poured into a glass bowl in circular movements until the vessel is full. In order to achieve a straight surface, the excess foam is now removed with a spatula. Then the jar is weighed. The vessel filled with foam is then compared with the mass of the same volume of water. The foam density can be calculated by dividing the mass of the foam in grams by the mass of the same volume of water in grams. A total of three determinations are carried out according to this procedure, whereby no individual value may deviate from the mean value by more than 20%.
A 50 ml burette with an internal diameter of 15 mm is used to test the expansion time. A plastic tube connects the burette with the applicator. As with the relative foam density, the container must be kept at 25 ° C for at least 24 hours. Then the container is shaken, creating a homogeneous phase. Then 5–10 ml of foam are released into the void. The applicator is connected to the burette and 30 ml of foam are dispensed. The expanding volume is then read every 10 seconds until the maximum volume has been reached. 3 determinations are carried out, whereby the maximum volume should be reached after 5 minutes at the latest.
Tampons containing active ingredients
According to the European Pharmacopoeia, vaginal tampons are solid, single-dose preparations that are used vaginally for a limited period of time. The active ingredient-containing tampons can consist of materials such as cellulose, collagen or silicone. This base is impregnated with one or more active ingredients. When labeling, according to the Pharmacopoeia, it is important to ensure that the amount of the active ingredient or ingredients is specified in relation to one tampon.
See also
Individual evidence
- ↑ a b c d e f g h i j k Deutscher Apotheker Verlag (Ed.): European Pharmacopoeia, 8th edition . 1st edition. Deutscher Apotheker Verlag, Stuttgart 2014, ISBN 978-3-7692-6512-5 .
- ^ NuvaRing. Retrieved July 4, 2017 .
- ↑ European Directorate for the Quality of Medicines & HealthCare: Vaginal delivery system . In: EDQM (Ed.): Standard Terms . March 14, 2006.
- ↑ Package insert NuvaRing vaginal ring. Retrieved July 4, 2017 .
- ↑ Contraception without the pill: vaginal ring: a well-rounded contraceptive . In: Deutsche Apotheker Zeitung . No. 6 , 2003 ( deutsche-apotheker-zeitung.de [accessed July 4, 2017]).