High potency dosage forms

In the human market, oral and parenteral dosage forms are prepared from the crystal. However, because of the extremely high potency, more dilute (0.1—10%) forms are avabable. These include dilutions with mannitol, triturations on dicalcium phosphate or resins, and spray-dried forms. Prices for these forms are driven by that of the crystal, which in early 1996 was ca 9.50/gram (95). Prices for the vitamin have risen during the first half of the 1990s. However, Htde growth in price beyond inflation is anticipated. 

Buccal Rapid onset of action No first-pass metabolism Dosage form recoverable Convenient Taste Only suitable for low dose (high potency) drugs Tablets, mouthwashes... 

The first four items listed above are directly related to the manufacture and validation of solid dosage forms. Items 1 and 3 are normally associated with variability in the manufacturing process, while items 2 and 4 are usually influenced by the selection of the ingredients in the product formulation. With respect to content uniformity and unit potency control (item 3), adequacy of mixing to assure uniformity and homogeneity is considered a high-priority concern. 

Depending on the location of ocular inflammation, a specific corticosteroid in a specific dosage form may be chosen. For instance, a corticosteroid of high potency, such as prednisolone acetate, fiuorometholone, or dexamethasone, may be chosen for deep-seated inflammation of the uveal tract. Further treatment of such inflammation may take the form of subtenon injections or oral (systemic) administration of selected corticosteroids, depending on the indication and the dosage forms available. For inflammation of a more superficial nature, the lower strengths of prednisolone acetate or the lower-potency corticosterioids, such as hydrocortisone or medrysone, will usually be chosen. 

In some cases, medications that cost more may be more cost effective. This is particularly true with pancreatic enzymes and the microencapsulated enteric-coated dosage forms. These latter products may cost more per unit, but they offer greater patient acceptance and compliance when compared to uncoated tablets. In addition, when cost is based on the total number of tablets or capsules per day, rather than the cost of a single tablet or capsule, the high-potency preparations are usually similar in price to the uncoated products. The addition of an H2-receptor antagonist or proton pump inhibitor may actually be cost effective for patients who are not adequately controlled on maximal enzyme therapy. 

Used as described above, NIR has a detection limit of 0.1% for solids. High-potency drugs constitute a small percentage of the dosage form, making accurate quantitation of drug by NIR difficult. In a 1990 paper by Corti et al. [27], an extraction procedure was used to improve the detection limit of oral contraceptives, small tablets with a low-concentration of drug. 

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