Solid dosage forms suppositories

Rectal Administration. The administration of drugs by a solid rectal dosage form (i.e., suppositories) results in a wide variability in the rate and extent of absorption in children [79]. This fact, coupled with the inflexibility of a fixed dose, makes this a route that should not be promoted for pediatric patients. At least one death involving a 7-month-old infant can be directly attributed to the use of solid rectal dosage form of a therapeutic dose of morphine [80]. 

Solid oral dosage forms, particularly tablets, are the preferred type of formulation in the United States. Not only are these products widely accepted by consumers, but they are also relatively cheaper to develop and manufacture than oral liquids or suspensions, par-enterals, or suppositories. Figure 4 shows, quite clearly, that even the elderly primarily make use of solid oral dosage forms [162]. 

A change in the container closure system of unit dose packaging (e.g., blister packs) for nonsterile solid dosage fonn products, as long as the new package provides the same or better protective properties and any new primary packaging component materials have been used in and been in contact with CDER-approved products of the same type (e.g., solid oral dosage form, rectal suppository). 

The dissolution test is required for all solid oral dosage forms. It is also required for special dosage forms such as stents, implants, ointments, powders, creams, suppositories, and suspensions. The development of a meaningful test with clinically relevant specifications is becoming of primary importance. No longer is the test merely a quality control tool, although understanding the product quality is still a very important attribute of the dissolution test. 

More elaborate sample preparation is often needed for complex sample matrices, e.g., lotions and creams. Many newer SP technologies such as solid-phase extraction (SPE), supercritical fluid extraction (SFE), pressurized fluid extraction, accelerated solvent extraction (ASE), and robotics are frequently utilized (see Ref. [2]). Dosage forms such as suppositories, lotions, or creams containing a preponderance of hydrophobic matrices might require more elaborate SP and sample cleanup, such as SPE or liquid-liquid extraction. 

Suppositories are solid dosage forms that are used to administer medieine through the rectum, vagina, or urethra. They are of different sizes or shapes, depending upon... 

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

Capsules, particularly soft capsules, have been used as vaginal drug delivery systems, but with modest popularity. These systems are relatively stable, particularly when compared with semisolid formulations or vaginal suppositories, being an adequate way to deliver liquid drugs within a solid dosage form. 

Suppositories are solid dosage forms intended for insertion in body cavities like rectum, vagina, and occasionally in the urethra for local or systemic effects. The length, shape, and weight of these depend on the body cavity it is used for. These melt, soften, or dissolve after application depending on the type of suppository base applied. Cocoa butter base suppositories usually melt in contact with the body temperature. Other bases, such as polyethylene glycol, glycerin. 

Waxes have been used by the pharmaceutical industry for many years. Their applications in semisolid preparations, including ointments, creams, or lotions, and in suppositories are well known and numerous publications exist on this topic. Because of their lipophilic properties, waxes have been used in sustained-release single or multiple unit solid dosage forms. This article reviews the different uses of waxes as sustained-release carrier or coating materials. 

Cetyl alcohol is widely used in cosmetics and pharmaceutical formulations such as suppositories, modified-release solid dosage forms, emulsions, lotions, creams, and ointments. 

Glyceryl monostearate is a lubricant for tablet manufacturing and may be used to form sustained-release matrices for solid dosage forms.Sustained-release applications include the formulation of pellets for tablets or suppositories and the preparation of a veterinary bolus. Glyceryl monostearate has also been used as a matrix ingredient for a biodegradable, implantable, controlled-release dosage form. ... 

The plant is designed to produce oral solid dosage forms as well as liquid dosage forms, ointments, creams, suppositories, and sterile injectable products. 

Liquid dosage forms Creams/ointments/ suppositories Solid dosage forms Cleaning... 

Dosage forms are indicated as follows I, regular or long-acting injection L, oral liquid or oral liquid concentrate O, oral solid S, suppository SR, oral, sustained-release. 

For rectal administration an active substance can be formulated into a suppository (solid dosage form) or in an enema (liquid dosage form). The desired miset of action is important for the choice. For a rapid onset an enema is preferable, because a suppository base has to melt or to dissolve first. A suppository may be preferred because its use is easier and more patient-friendly. An enema is the best choice when a local effect over a large surface is desired, for instance in the treatment of ulcerative colitis. From a practical viewpoint an enema can be prepared faster, but is more sensitive to chemical degradation, due to the presence of water. 

Suspensions are regularly used as a dosage form. Examples can be found in oral suspensions (co-trimoxazol suspension), dermatological preparations (zinc oxide or calamine lotions like Zinc oxide lotion NRF (Table 18.17)), parenteral preparations (corticosteroid injections, medroxyprogesterone injection) and a suspension in the form of a solid dispersed in a melted fat base as in the case of suppositories. 

The dispersion of a solid into a Uquid can be found in dosage forms such as mixtures, dermatologic preparations, suppositories, enemas, and eye drops. Qiaracteristic for this process is the requirement of energy to obtain a homogeneous mixture furthermore, often separation occurs upon storage. This does not apply for suppositories, ointments or creams, which during the preparation are a dispersion of a solid into a liquid, but, once soUdiUed, form a semisoUd dispersion. 

Meeting the requirements for disintegraticai is a minimum condition for the release of the active substance from the dosage form. For solid dosage forms and dispersions (suspensions, most suppositories) the active substance still has to dissolve to be available for absorption (see Sect. 16.1.4). 

The determination of the dissolution rate of the active substance from the dosage form is relevant for solid dosage forms and dispersions, especially when the substance is poorly soluble (see Sect. 16.1.4). Only dissolved substances are available for absorption. Ph. Eur. describes in chapter 2.9.3 Dissolution test for solid dosage forms the equipment, the method of analysis and the interpretation of the determination of the dissolution rate of tablets and capsules. For suppositories it is described in Ph. Eur. chapter 2.9.42 Dissolution test for lipophilic solid dosage forms . 

Drug dosage forms can be classified by consistency as solid, semisoUd, and liquid formulations. Solid formulations include powders, granules, microcapsules, capsules, dragees, suppositories, and decoctions. Ointments, creams, gels, and pastes are semisolid formulations, and solutions, emulsions of low viscosity, and suspensions make up the class of liquid formulations. Products applied to the skin border between pharmaceuticals and cosmetic usage (30). 

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