Active Ingredients: Azithromycin
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A preferred binder for azithromycin tablets is pregelatinized starch available, for example, under the registered trademark Starch 1500, from Colorcon, Inc.
Also useful as flavors are vanilla, citrus oil, including lemon, orange, grape, lime and grapefruit, and fruit essences, including apple, banana, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot, and so forth.
Generally the flavoring will be present in an amount of from 0.
Examples are spray-dried or anhydrous lactose, sucrose, dextrose, mannitol, sorbitol, starch e. Lubricants can also be employed herein in the manufacture of certain dosage forms, and will usually be employed when producing tablets.
Examples of lubricants are magnesium stearate, stearic acid, glycerylbehaptate, polyethylene glycol, ethylene oxide polymers for example, available under the registered trademark Carbowax from Union Carbide, Inc.
Preferred lubricants are magnesium stearate, and mixtures of magnesium stearate with sodium lauryl sulfate.
Lubricants generally comprise 0. A coloring agent is an optional ingredient in the compositions of this invention, but when used will generally be present in an amount up to about 3.
The choice of processing approach depends upon the properties of the drug and chosen excipients, for example particle size, blending compatibility, density and flowability.
For azithromycin tablets, granulation is preferred, with wet granulation being most preferred. In a preferred embodiment, tablets of this invention are film-coated to provide ease of swallowing and an elegant appearance. Many polymeric film-coating materials are known in the art.
A preferred film-coating material is hydroxypropylmethylcellulose HPMC.
The tableting process itself is otherwise standard and readily practiced by forming a tablet from a desired blend or mixture of ingredients into the appropriate shape using a conventional tablet press.
The azithromycin dosage forms of this invention also include powders to make oral suspensions, and also the oral suspensions themselves. Generally the powder is a non-caking, free flowing powder which is sold direct to pharmacies or other retail outlets and then made up into the actual suspension by a pharmacist.