FORM-2
THE PATENT ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10 and Rule 13)
ORAL DOSAGE FORMULATIONS AND PROCESS OF PREPARATION THEREOF
M. J. BIOPHARM PVT. LTD.
an Indian Company
of 113, Jolly Maker Chambers No. 2, Nariman Point, Mumbai-400 021, Maharashtra, India,
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION

The present invention relates to oral dosage formulations and process of preparation thereof.
3-Hydroxy-2,4,6-trimethylpyridine succinate salt and other such salts belong to a group of new biologically active compounds exhibiting important pharmacological activities such as antioxidant, geroprotective and ant-ischemic action. To deliver or dispense a unit dose of the pharmaceutically active agent, a stable and pharmaceutically acceptable dosage form is required.
It is an object of the present invention is to prepare oral pharmaceutical dosage forms with unit or multi dose options containing biologically active compounds with antioxidant, gero-protective and anti-ischemic properties either alone or in combination with other pharmaceutically active ingredients.
It is another object of this invention to provide a commercially acceptable process for preparation of oral pharmaceutical dosage forms containing biologically active compounds with antioxidant, gero-protective and anti-ischemic properties, either alone or in combination with other pharmaceutically active ingredients, with desirable release rates so as to facilitate in-vivo absorption of the drug substance.
In accordance with this invention there is provided an oral pharmaceutical dosage form comprising at least one pharmaceutically acceptable parent base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof, either alone or in combination with other pharmaceutically active ingredients along with a carrier and excipients.


Pharmaceutically acceptable salt of 3-Hydroxy-2, 4, 6-trimethylpyridine is selected from a group of pharmaceutically acceptable salts with organic acids or mineral acids consisting of salicylate, maleate, succinate, fumarate, malate, tartrate, oxalate, citrate, pamoate, hydrochloride, hydrogen sulfate, sulfate, methanesulphonate, and benzenesulfonate.
Besides at least one pharmaceutically acceptable parent-base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof and one or more carriers and excipients. The oral preparations in accordance with this invention can also contain additives. Various types of additives that can be used include: fillers, binders, lubricants, wetting agents, stabilizers, emulsifiers, dispersants, preservatives, sweeteners, colorants, flavorings, aromatizers, thickeners, diluents, buffer substances, solvents, solubilizers, agents for achieving a depot effect, salts for altering the osmotic pressure, coating agents and the like.
In accordance with one of the preferred embodiments of this invention, the oral pharmaceutical dosage form comprises a capsule made up of gelatin or other pharmaceutically acceptable raw materials, the active pharmaceutical ingredient and other excipients.
Capsule formulation may contain granules blend made with at least one pharmaceutically acceptable parent base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof along with microcrystalline cellulose, lactose, maize starch, sodium starch glycollate, talc, colloidal anhydrous silica, magnesium stearate or other such pharmaceutically acceptable excipients.


In accordance with another preferred embodiment, the solid oral pharmaceutical dosage form is in the form of a tablet comprising the active pharmaceutical ingredient/s and excipients.
In accordance with this invention there is also provided a process for preparation of pharmaceutically acceptable solid oral dosage forms containing at least one pharmaceutically acceptable parent base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof either alone or in combination with other pharmaceutically active ingredients.
The formulated oral dosage forms in accordance with this invention are pharmaceutically stable and exhibit good compliance as per standards established for such dosage forms.
While considerable emphasis has been placed herein on the specific ingredients of the preferred composition, it will be appreciated that many additional ingredients can be added and that many changes can be made in the preferred composition without departing from the principles of the invention. These and other changes in the preferred composition of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as