Semisolid ointments

Soft capsules are also used for semisolid (ointment) e.g. eye applicaps of Chloromycetin. 

Topicals— These are semisolid preparations such as creams, ointments, or gels intended to be applied to the skin or certain mucous membranes... 

To be semisolid, a system must have a three-dimensional structure that is sufficient to impart solidlike character to the undistributed system that is easily broken down and realigned under an applied force. The semisolid systems used pharmaceutically include ointments and solidified w/o emulsion variants thereof, pastes, o/w creams with solidified internal phases, o/w creams with fluid internal phases, gels, and rigid foams. The natures of the underlying structures differ remarkably across all these systems, but all share the property that their structures are easily broken down, rearranged, and reformed. Only to the extent that one understands the structural sources of these systems does one understand them at all. 

Creams are semisolid emulsion systems having a creamy appearance as the result of reflection of light from their emulsified phases. This contrasts them with simple ointments, which are translucent. Little agreement exists among professionals as to what constitutes a cream, and thus the term has been applied both to absorption bases containing emulsified water (w/o emulsions) and to semisolid o/w systems, which are physicochemically totally different, strictly because of their similar creamy appearances. Logically, classification of these systems should be based on their physical natures, in which case absorption bases would be ointments and the term cream could be reserved exclusively for semisolid o/w systems, which in all instances derive their structures from their emulsifiers and internal phases. 

The amounts of ointments and creams people apply are highly individualized. So are the techniques of application. Some patients vigorously rub semisolid formulations into the skin, while others just spread films until they are more or less uniform over the desired area. While pharmacokinetic assessments of a system s delivery attributes is ordinarily done using normal skin (in vitro) or on healthy volunteers (in vivo), the site of its clinical deployment is usually anything but normal. Rather, it is determined by the skin condition to be treated. Clearly, the manufacturer is without control over how a disease is expressed in a particular patient. For many diseases, disease manifestation can be anywhere on the body. Moreover, from individual to individual it varies in intensity and vastness. Thus, more area may be involved in one case than in another, and the barrier function of the skin may be more or less intact in any instance. This creates a set of imponderables with respect to delivery, efficacy, and safety. 

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

Method for semisolids (membrane method) Mass transport from water-miscible gels or water-immiscible ointment bases 22,23... 

Calculations Involving Ointments, Creams, and Other Semisolids... 

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

Ointments are semisolid preparations that are intended for external use. Ointments may contain either finely powdered drugs or their mixtures, liquids, and other drug forms incorporated into appropriate bases. They are applied to the skin for their physical effects as emollients (which make the skin more pliable), protectants, lubricants, and drying agents. Ointment bases are also used as vehicles in which to incorporate topical medications which exert specific effect. There are four types of ointment bases, namely, oleaginous, absorption, water removable, and water soluble bases. 

Pastes are also semisolid preparations intended for external application to the skin, and differ from ointments and creams in that they contain a high solid content. Pastes are made stiff by the addition of powders such as starch, zinc oxide, calcium carbonate or their mixtures. 

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. 

When semisolid preparations of certain strength are diluted with ointment bases (also referred to as diluents), the strength of the mixture will be lowered. The percentage strength decreases as the quantity increases. To calculate the percent by weight strength of a semisolid mixture, an equation may be used as follows ... 

CHAPTER 7 CALCULATIONS INVOLVING OINTMENTS, CREAMS, AND OTHER SEMISOLIDS... 

Ointments are semisolid preparations to be applied externally to the skin or mucous membranes they soften or melt at room temperature. Pastes are thick, stiff ointments... 

The generally low lipid content and the poor viscosity of lipid nanodispersions make these preparations, as they are, less suitable for dermal drug application. The handling of the preparation by the patient is improved by SLN incorporation into ointments, creams, and gels. Alternatively, ready-to-use preparations may be obtained by one-step production, increasing the lipid phase to at least 30%. However, increasing the lipid frequently results in an unwanted increase in particle size. Surprisingly, it has been found that very concentrated (30 to 40%) semisolid cetyl palmitate formulations preserve the colloidal particle size [10]. 

Liquids/semisolids Foams, enemas, ointments and gels ... 

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... 

Ointment An unctuous semisolid for topical application. Typical ointments are based on petrolatum. An ointment does not contain sufficient water to separate into a second phase at room temperature. Water soluble ointments may be formulated with polyethylene glycol. 

Structure Forming Excipient An excipient which participates in the formation of the structural matrix which gives an ointment, cream or gel etc., its semisolid character. Examples are gel fonning polymers, petrolatum, certain colloidal inorganic solids (e.g., bentonite), waxy solids (e.g., cetyl alcohol, stearic acid), and emulsifiers used in creams. 

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. 

Semisolid systems fulfill a special topical need by being able to cling to the surface of application. Such systems are plastic in behavior, which allows semisolids to be mechanically spread uniformly over a surface as an immobile film. For the production of lipid-free ointments, pastes, and creams, several gel-forming polysaccharides are being used. As an emulsifier they can provide a three-dimensional matrix which... 

G. Creams or ointments Semisolid preparations intended for topical application. Excipients include petrolatum, isopropyl... 

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