Pharmaceutical dosage forms

AH steps of manufacture are monitored for antibiotic potency, purity, stabiUty, and bioavailabihty by quaUty control methods. In addition, each batch of bulk powder and each lot of finished pharmaceutical dosage form must be certified by the FDA. During all stages of manufacture the FDA requires compliance with specified standards. 

As a therapeutic agent, ch oline is adininistered orally in the form of symps or elixers containing the chloride, citrates or bitartrate, or in the form of compressed tablets or capsules of the dihydrogen citrate. Choline is also given in small doses as a nutritional supplement in combination with a variety of other materials. In dry pharmaceutical-dosage forms, the dihydrogen citrate is usually preferred because of its lower tendency to absorb atmospheric moisture. Both salts have been used parenteraHy. 

J. W. McGiuity, ed.. Aqueous Polymeric Coatingsfor Pharmaceutical Dosage Forms, Marcel Dekker, Inc., New York, 1989. 

B. Idson, in H. A. Lieberman and co-eds.. Pharmaceutical Dosage Forms, Disperse Systems, Vol. 1, Marcel Dekker, New York, 1988, Chapt. 6. 

Kinetics can also be applied to the optimization of process conditions, as in organic syntheses, analytical reactions, and chemical manufacturing. This last example constitutes an important aspect of chemical engineering. Yet another practical use of chemical kinetics is for the determination and control of the stability of commercial products such as pharmaceutical dosage forms, foods, paints, and metals. 

Pharmaceutical Dosage Forms That Should not be Crushed... 

SS Davis, JG Hardy, JW Fara. Transit of pharmaceutical dosage forms through the small intestine. Gut 27 886-892, 1986. 

A rational way to develop approaches that will increase the stability of fast-degrading drugs in pharmaceutical dosage forms is thorough study of the factors that can affect such stability. In this section, the factors that can affect decomposition rates are discussed it will be seen that under certain conditions of pH, solvent, presence of additives, and so on, the stability of a drug may be drastically affected. Equations that may allow prediction of these effects on reaction rates are discussed. 

In many pharmaceutical dosage forms, it may be necessary to incorporate water-miscible solvents to... 

Current Good Manufacturing Practices [135] establish the requirements for maintaining a stability program and require that most pharmaceutical dosage forms have an established expiration date supported by test data [134]. There are few allowable exceptions. 

This chapter describes the basic principles involved in the development of disperse systems. Emphasis is laid on systems that are of particular pharmaceutical interest, namely, suspensions, emulsions, and colloids. Theoretical concepts, preparation techniques, and methods used to characterize and stabilize disperse systems are presented. The term particle is used in its broadest sense, including gases, liquids, solids, molecules, and aggregates. The reader may find it useful to read this chapter in conjuction with Chapters 8, 12, and 14, since they include some of the most important applications of disperse systems as pharmaceutical dosage forms [1]. 

An interface is defined as a boundary between two phases. The solid/liquid and the liquid/liquid interfaces are of primary interest in suspensions and emulsion, respectively. Other types of interfaces such as liquid/gas (foams) or solid/gas interfaces also play a major role in certain pharmaceutical dosage forms, e.g., aerosols. 

Table 6 Relationship Between the Use of Surfactants in the Preparation of Pharmaceutical Dosage Forms, Their Dispersibility in Water and Their HLB Values...

Latices and pseudolatices are widely used for the coating of solid pharmaceutical dosage forms such as tablets, capsules, and pellets. The major advantage compared to conventional coating techniques is the avoidance of organic solvents. 

MD Donovan, DR Flanagan. Bioavailability of disperse dosage form. In HA Lieberman, MM Rieger, GS Banker, eds. Pharmaceutical Dosage Forms Disperse Systems, Vol. 1. 2nd ed. New York Marcel Dekker, 1996, pp 315-376. 

TA Wheatley, CR Steuernagel. Latex emulsions for controlled drug delivery. In JW McGinity, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms,... 

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