Abstract: A particulate co-processed composition comprising microcrystalline cellulose and at least one sugar alcohol is disclosed. A preferred sugar alcohol is mannitol. The composition has an improved compactability profile, lubricant sensitivity, and ejection profile compared to microcrystalline cellulose and the at least one sugar alcohol, either alone or in combination as a simple dry blend, in the preparation of solid dosage formulations, such as tablets. Tablets comprising the particulate co-processed composition, an active, and, optionally, one or more other excipients, and method for their preparation, are also disclosed.

Abstract: A method for the preparation of microcrystalline cellulose containing tablets by roller compaction followed by tabletting is disclosed. A tablet formulation is converted to a dry granulate by roller compaction, and the dry granulate lubricated dry granulate and compacted to a tablet. The tablet formulation comprises at least one active, an microcrystalline cellulose containing material, and, optionally other pharmaceutically acceptable excipients. The microcrystalline cellulose containing material has a maximum primary compaction tensile strength of at least 9 MPa or at least 9.5 MPa and a secondary compaction tensile strength of at least 5 MPa, at least 5.5 MPa, or at least 6 MPa. A method for evaluating binders is also disclosed.

Abstract: A method for the preparation of microcrystalline cellulose containing tablets by roller compaction followed by tabletting is disclosed. A tablet formulation is converted to a dry granulate by roller compaction, and the dry granulate is lubricated and compacted to a tablet. The tablet formulation comprises at least one active, an microcrystalline cellulose containing material, and, optionally other pharmaceutically acceptable excipients. The microcrystalline cellulose containing material has a maximum primary compaction tensile strength of at least 9 MPa or at least 9.5 MPa and a secondary compaction tensile strength of at least 5 MPa, at least 5.5 MPa, or at least 6 MPa. A method for evaluating binders is also disclosed.

Abstract: The invention is directed to the functionality and performance of superdisintegrants in orally disintegrating tablets (ODT). The invention can be an aged direct compression ODT having between about 0.3% to about 2% (wt/wt) sodium croscarmellose relative to the total weight of the ODT, a polyol matrix, optionally a lubricant, and an active pharmaceutical or nutraceutical ingredient, in which after storage for four months the ODT has a disintegration time using an excess water test that is less than 30 seconds and a tensile strength greater than 0.5 MPa. The invention is also directed to a direct compression ODT, consisting essentially of about 0.5% to 2.0% sodium croscarmellose, from 0.1% to 2.0% lubricant, an API, up to 10% (wt/wt) microcrystalline cellulose, optionally one or more colorants, sweeteners, fragrances, flavor compounds, and/or flavor blockers, and the balance spray-dried mannitol.

Abstract: A spinal restraint apparatus for use in emergency extrication, where potential back, neck and spinal injuries may exist. The apparatus comprises a collar neck support device and an elongate support member. Further described are methods of using the apparatus.

Abstract: A method for the preparation of microcrystalline cellulose containing tablets by roller compaction followed by tabletting is disclosed. A tablet formulation is converted to a dry granulate by roller compaction, and the dry granulate lubricated dry granulate and compacted to a tablet. The tablet formulation comprises at least one active, an microcrystalline cellulose containing material, and, optionally other pharmaceutically acceptable excipients. The microcrystalline cellulose containing material has a maximum primary compaction tensile strength of at least 9 MPa or at least 9.5 MPa and a secondary compaction tensile strength of at least 5 MPa, at least 5.5 MPa, or at least 6 MPa. A method for evaluating binders is also disclosed.

Abstract: A particulate co-processed composition comprising microcrystalline cellulose and at least one sugar alcohol is disclosed. A preferred sugar alcohol is mannitol. The composition has an improved compactability profile, lubricant sensitivity, and ejection profile compared to microcrystalline cellulose and the at least one sugar alcohol, either alone or in combination as a simple dry blend, in the preparation of solid dosage formulations, such as tablets. Tablets comprising the particulate co-processed composition, an active, and, optionally, one or more other excipients, and method for their preparation, are also disclosed.

Abstract: The present invention is directed to compositions containing: (i) sugar and/or a sugar substitute and (ii) microcrystalline cellulose present in an amount equal to greater than 41% of the total weight of the composition. The present invention is also directed to compositions containing: (i) sugar and/or a sugar substitute and (ii) microcrystalline cellulose having an average particle size equal to or less than 20 microns and present in an amount equal to or greater than 20% of the total weight of the composition. The compositions of the present invention are useful in coating a wide variety of solid forms such as pharmaceutical dosage forms, veterinary dosage forms, nutraceutical dosage forms, food, industrial material, cosmetic material or oral care material. The compositions of the invention are also useful as films such as cast films. The present invention is also directed to methods of making such compositions, as well as methods of coating such compositions on solid forms.