Orally disintegrating tablets dosage forms

Oral tablets 2.5 or 5 mg at onset as regular or orally disintegrating tablet can repeat after 2 hours if needed Optimal dose is 2.5 mg maximum dose is 10 mg/day Do not divide ODT dosage form... 

About 75 mg of carbidopa is required to effectively block L-AAD, but some patients may need more. Carbidopa/L-dopa is most widely used in a 25-mg/ 100-mg tablet, but 25-mg/250-mg and 10-mg/100-mg dosage forms are also available. Controlled-release preparations of carbidopa/L-dopa are available in 50-mg/200-mg and 25-mg/100-mg strengths. For patients with difficulty swallowing, an orally disintegrating tablet is available. If peripheral adverse effects are prominent, 25-mg carbidopa (Lodosyn) tablets are available. 

In order for absorption to occur, a drug or a therapeutic agent must be present in solution form. This means that drugs administered orally in solid dosage forms (tablet, capsule, etc.) or as a suspension (in which disintegration but not dissolution has occurred) must dissolve in the gastrointestinal (GI) fluids before absorption can occur (Fig. 8.1). 

The relationship between manufacturing variables and therapeutic action of compressed oral dosage forms was noted early in the history of mass-produced medicines. Caspari (6), in the late 19th century, recommended that a tablet have a composition that promotes disintegration and subsequent solution in the stomach to avoid impairment of its therapeutic value. The implementation of a disintegration procedure to... 

The development of oral dosage forms that disintegrate or dissolve in the mouth is providing LCM opportunities for pediatric, geriatric, or bedridden patients who have difficulty in swallowing. They are also being used by active adult patients who may not have ready access to water for swallowing tablets or capsules. 

Disintegration into fine particles is the first process that occurs when a drug is administered as a solid oral dosage form. The effectiveness of a tablet or solid dosage form in releasing the drug depends on the rate of disintegration. Dissolution rate is the rate at which the solid fine particles dissolve in a solvent. 

Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the resultant formulation, for example, fillers, disintegrants, binders, lubricants and glidants. An added complexity is the fact that certain excipients can have different functional roles in different formulation types. Thus, lactose is widely used as a filler or diluent in solid oral dosage forms, for example, tablets and capsules [2] and as a carrier for inhalation products [3]. 

Lubrication is an important unit operation in manufacturing solid oral dosage forms, particularly when using a direct compression platform. Pharmaceutical lubricants can have a significant impact on product performance (e.g., disintegration and dissolution) as well as manufacturability. Lubrication is one of the most critical aspects of a tablet formulation. A lubricant is intended to reduce the friction between the tablet surface and die wall during and after compaction to enable easy ejection of the tablet. In low-dose dmg product development, three issues are associated with lubricating a direct compression formulation ... 

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