Ointment dosage forms

For liquid (e.g., solution, suspension, elixir) and semisolid (e.g., creams, ointments) dosage forms, a change to or in polymeric materials (e.g., plastic, rubber) of primary packaging components, when the composition of the component as changed has never been used in a CDER-approved product of the same dosage form and same route of administration. For example, a polymeric material that has been used in a CDER-approved topical ointment would not be considered CDER-ap-proved for use with an ophthalmic oinhnent. 

There are two primary methods of manufacturing ointment dosage forms incorporation and fusion. Each may be used on a small scale (laboratory) or large scale (industry) for the manufacture of semisolid dosage forms. 

For liquid (e.g., solution, suspension, elixir) and semisolid (e.g., creams, ointments) dosage forms in permeable or semipermeable container closure systems, a change to an ink or adhesive... 

Ophthalmic Dosage Forms. Ophthalmic preparations can be solutions, eg, eye drops, eyewashes, ointments, or aqueous suspensions (30). They must be sterile and any suspended dmg particles must be of a very fine particle size. Solutions must be particle free and isotonic with tears. Thus, the osmotic pressure must equal that of normal saline (0.9% sodium chloride) solution. Hypotonic solutions are adjusted to be isotonic by addition of calculated amounts of tonicity adjusters, eg, sodium chloride, boric acid, or sodium nitrate. 

The choice of an antibiotic agent for acute bacterial conjunctivitis is largely empiric. The initial treatment needs to include Staphylococcus coverage, but also may be chosen on the basis of cost and side-effect profile.13,14 In general, ointments are a good dosage form for children. Adults prefer drops because they do not interfere with vision.14... 

With transdermal dosage forms being of great importance of late, it is advisable to test for compatibilities with ointment excipients and with polymers (e.g., ethylvinyl polymer, if that is the desired barrier). 

Behind the relatively straightforward compositional nature of ophthalmic solutions, suspensions, and ointments, however, lie many of the same physicochemical parameters that affect drug stability, safety, and efficacy, as they do for most other drug products. But additionally, specialized dosage forms present the ophthalmic product designer with some extraordinary compositional and manufacturing challenges. These... 

B. Semisolid Dosage Forms Ophthalmic Ointments and Gels... 

The present chapter deals with calculations involving topical semisolid dosage forms, which include ointments, creams, and pastes. 

Amongst the various types of semisolid preparations, ointments represent the type of extemporaneous preparations most likely to be prepared by a pharmacist. A variety of ingredients may be included in the formula of semisolid dosage forms. 

The standard temperature for the dissolution medium is 37 0.5°C for oral dosage forms. Slightly increased temperatures such as 38 0.5°C have been recommended for dosages forms such as suppositories. Lower temperatures such as 32 0.5°C are utilized for topical dosage forms such as trans-dermal patches and topical ointments. 

Purified drug substances are mixed with excipients into finished dosage forms sohds, liquids, parenterals, inhalants, and ointments and creams, then packaged and labeled and shipped for distribution. 

Several dosage forms carry an increased risk of degradation or adjunct formation. Products such as injections and aerosols are more likely to interact with volatiles or extractables from packaging and closure systems. Tablets have the potential to form adjuncts with excipients (specifically, lactose has been shown to form adjuncts in tablets). Non-CFC propellants in aerosols have a large number of impurities that typically do not interact with drug substances, but the potential for these interactions does still exist. Creams, ointments, lotions, and other such products will each have specific interactions that should be considered while evaluating the impurity profile of a drug product. 

Adhesive ointments have not been investigated as extensively as have adhesive tablets or adhesive patches. Nevertheless, attempts have been made to utilize this dosage form primarily for local therapy [56]. 

Buccal dosage forms can be of the tablet, patch, gel, or ointment type and can be employed for local or systemic delivery. For local deliveiy, conventional dosage forms such as solutions and various types of tablets (immediate release, effervescent, etc.) are more suitable. These forms generally have uncontrolled drug release with subsequent variable absorption and short residence times, and may not provide sufficient bioavailability. Novel dosage forms such as adhesive tablets, patches, gels, and... 

The inclusion of the a routine microbial limit test in a marketed product stability protocol depends on the pharmaceutical dosage form. Typically, the test would be used only for nonsterile products, especially oral liquids, nasal sprays, and topical liquids, lotions, and creams that have sufficient water activity to support the growth of microorganisms. In contrast, tablets, powder- and liquid-filled capsules, topical ointments, vaginal and rectal suppositories, nonaqueous liquids and inhalation aerosols with a water activity too low to allow for the product to support the growth of microorganisms would not be routinely tested. 

The dosage forms applied locally to the skin are powders, paste, lotions, ointments, creams, plasters and jellies. They are used for their antiseptic, antipruritic, analgesic, local anaesthetic and other related effects. 

Pastes may be defined as a semisolid dosage form that contains a large proportion (i.e., 20-50%) of solids finely dispersed in a fatty vehicle (basically an ointment base) for external application to the skin. The presence of a high concentration of solids makes them much stiffer than ointments. Like ointments, pastes form an unbroken... 

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