Suppositories and Pessaries

Suppositories and pessaries— These are preparations intended for either rectal or vaginal administration of drugs. They are formulated with a suitable base that melts at body temperature. 

Liquids and semisolids. Include oral liquids, injectable, aqueous, and oil-based liquids, emulsions, suspensions, dispersions, solutions, drops, lotions, creams, ointments, pastes, gels, liniments, aerosols and foams, suppositories, and pessaries. 

The large-scale manufacture of suppositories and pessaries uses either the fusion method where the drug is dispersed in a molten base and the mixture poured into molds to solidify, or the cold compression methodJ In the latter process, the medicament and cold-grated base, usually theobroma oil or witepsol base, are intimately mixed and placed in a cylinder. The mass is extruded by means of a piston through small holes that connect with the mold. The cavities are filled by pressure with the mass which is prevented from escaping by movable end plates. The plates are removed and the suppositories ejected by further extrusion. The extrusion equipment is chilled to prevent melting of the components due to the heat generated by the friction of compression. 

The above examples have only scratch the surface of the expanding role of the pack. What about dermal patches, implants, insulin pens, pump systems, suppository and pessary delivery systems, nebulisation, puffer packs, Ocuserts , a review of unit dose applications, etc. Systems are now so numerous that doing a paper search and review would take several weeks. However, they do indicate the new roles which are being undertaken by the pack. Each new system challenges new sets of tests in order to evaluate performance and efficiency. 

Suppositories and pessaries that are not filled directly in strips (their primary container) if necessary suppositories can first be packaged separately in aluminium foil... 

A jar can be used as secondary container for single dose oral powders in powder paper or sachets, and for suppositories and pessaries in strips. 

For disintegration of suppositories the equipment and determination method are described in Ph. Eur. chapter 2.9.2 Disintegration of suppositories and pessaries . Fat suppositories have to melt within 30 min, water-soluble suppositories after 60 min. 

In many ways pharmaceutical dosage forms can be regarded as dispersions of drugs in carriers. Whereas this is utilised in solid dispersions, it is equally applicable to suppositories or pessaries, or indeed any system where heat (or solvent and subsequent evaporation) is used to produce a dispersion of a drug in a carrier. Thermal analysis, and especially DSC, can be used to measure the development of structure or subsequent storage. This can be reflected as an increase in fusion enthalpy on storage [110, 111] of solid dispersions, or conversion of the crystalline form, whether polyethylene glycol [110] or as a... 

Progesterone. Progesterone (1) is not orally active. Although seldom used clinically, it can be adrninistered as an intramuscular injection, pessaries, or suppositories in the treatment of menstmal disorders and habitual abortion (121). Progesterone can be recrystaUized from dilute alcohol and exists in two crystalline forms (122). It is soluble in chloroform and ethanol sparingly soluble in acetone, dioxane, ether, and fixed oils and practically insoluble in water (121). Two syntheses of progesterone (1) are described in Figure 3. 

Drugs may also be administered locally in the form of bougies, jellies for urethra, pessaries, vaginal tablets, creams and douches for vagina and suppositories for rectal administration. 

Solid dosage form includes capsules, granules, effervescent granules, powders, tablets, insufflations, suppositories (pessaries, bougies and ear cone) etc. 

Solids. Include tablets, capsules, powders, granules, lozenges, pastilles, suppositories, pessaries, pills, dressings, and dermal patches. May also include such devices as actuators. 

Orifices. Include eye, ear, nose, throat, rectal, vaginal, and the mouth as a route to the throat and lungs, orifices using suppositories, pessaries, drops, solutions, ointments, gases, vapors, aerosols, and inhalations. 

Vaginal pessaries or suppositories (the terms often used interchangeably) containing such substances as natural gums, fatty acids, alum, and rock salts were originally used in ancient Egyptian times as contraceptives. One of the earliest technical papers describing a... 

Conventional formulations intended for vaginal application include solutions, foams, creams, gels, tablets, and suppositories, in particular pessaries. 

A vaginal suppository based on bromocriptine was employed for the therapy of hyperprolactinemia [32]. The rationale of the local vaginal delivery of bromocriptine lies in the noteworthy side effects consequent to oral therapy gastrointestinal disorders, extensive hepatic degradation, and hypotension. The pessary based on bromocriptine proved to be effective in lowering serum prolactin to normal levels after 20 days of local therapy the treatment was well tolerated by the majority of the patients and a minimal vaginal irritation was observed. 

Parenteral delivery systems involve the use of needles. This is painful for the patient, as well as generally requiring the intervention of medical professionals. The oral route, which involves merely swallowing a tablet, liquid or capsule, thus represents a much more convenient and attractive route for drag delivery. Transdermal patches are also well accepted by patients and convenient. Some other dosage forms, for example nebulizers, pessaries and suppositories, may meet with more limited patient compliance. 

Oral transmucosal devices, such as sprays, tablets or patches, are also simple for the patient to use and might be expected to be more acceptable to the patient than the use of pessaries or suppositories for the intravaginal and rectal delivery routes respectively. 

Modem spermicides are produced in a variety of formulations, including gels, foams, creams, suppositories, pessaries, capsules, foaming tablets, and melting films. Spermicides are also used in conjunction with other methods, such as diaphragms, condoms, and sponges, but also with intrauterine contraceptive devices and methods based on fertility awareness (1). 

Aluminum oxide is used mainly in tablet formulations. It is used for decoloring powders and is particularly widely used in antibiotic formulations. It is also used in suppositories, pessaries, and urethral inserts. Hydrated aluminum oxide (see Section 18) is used in mordant dyeing to make lake pigments, in cosmetics, and therapeutically as an antacid. 

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