A dosage form according to the present invention may also include suitable noneffervescent, nonsuper disintegrants. In addition to storage stability, the dosage forms in accordance with the present invention are orally disintegrable. Ingredients were weighed and placed in the bowl of a high-shear granulator.
These can include, without limitation, particles, crystals, granulates, capsules, mini-tablets microparticles, microgranules, microcrystals or microcapsules. Particles, granules and crystals have their traditional meaning. The size of the granulate may also vary depending on whether or not it will be subsequently coated. Any other analytical technique which can provide this information may also be used.
The orally disintegrable dosage forms of the present invention include protected lorazepam particles. In one embodiment, lorazepam can be dissolved, dispersed or suspended in an appropriate carrier or solvent and sprayed onto some sort of solid support in a granulator. Such terms will be defined by the circumstances and the terms that they modify as those terms are understood by those of skill in the art.
Samples were assayed for potency at the end of five days and results were compared to non-stressed material from the same batch. In accordance with the present invention, the carrier particle size is preferably between about 10 microns and about 1, microns, more preferably between about 20 microns and microns.
They can depend on the degree of protection that is required, the amount of lorazepam to be delivered, the size of the dosage form, the type of cogranulate used, the type of binder used the concentration of binder in the wet granulate solution and in the resulting granulate and the like.
In both cases, all ingredients except magnesium stearate were weighed, sieved through a mesh screen, and mixed in an 1-qt V-blender for 30 minutes. Lubricants may also be used. The concentration of the lorazepam in the solvent will vary with the solvent, the coating material used, and whether or not a solution, suspension or dispersion is to be produced.
The lorazepam and polymer may be used together in a layer, may be used together in a binder or may be separate, as in separate layers or particles and a binder. The dosage form of claim 18 wherein said cogranulate material is selected from the group consisting of microcrystalline cellulose, carbonates, bicarbonates, carbohydrates and cellulosic materials and inert materials.
Following application of the over-coat solution, product was dried in the fluid bed for 10 minutes. Thus, there remains a need for orally disintegrating tablets containing lorazepam. The size of the carrier particles can vary considerably with, amongst other things, the application, volume of the carrier particles that will be used in the formulation, the type of dosage form in which it will be included, and the thicknesses of the layers that will coat it.
A lorazepam containing layering composition was prepared by mixing the following:.
A storage stable, orally disintegrable dosage form comprising: Carrier particles that are too small can be difficult to layer. This is based on the dried coated particle before and after coating. The acid sources or acid may be any which are safe for human consumption and may generally include food acids, acid anhydrides and acid salts.
Preferably, however, the lorazepam containing layer covers substantially all of the carrier particles to which it is applied it is possible to mix some coated and uncoated solid support if desired and each successive layer preferably does the same.
Larry BereuterDavid K. The protected lorazepam particles may also optionally include one or more coatings. It is understood, however, that in the mouth, not all of the dissolvable material contained within the dosage form has in fact dissolved or that the dosage form has completely disintegrated.