FORM-2
THE PATENT ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10 and Rule 13)
INJECTABLE PREPARATIONS AND A 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 injectable preparations and a process of preparation thereof.
3-Hydroxy-2,4,6-trimethylpyridine succinate and other such salts belong to a group of new biologically active compounds which exhibit antioxidant, geroprotective and anti-ischemic action. To deliver or dispense a unit dose of pharmaceutically active unit dose, a stable and pharmaceutically acceptable dosage form is required.
It is an object of this invention to prepare simple and cost effective injectable preparations containing biologically active compounds with antioxidant, gero-protective and anti-ischemic actions.
It is another object of this invention to prepare an injectable preparation containing biologically active compounds with antioxidant, gero¬protective and anti-ischemic actions.
Still another object of this invention is to provide a sterile injectable solution for injection for administering unit dose to a patient in clinical emergency situation.
In accordance with the present invention, there is provided a sterile, stable injectable preparation 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 any other pharmaceutically active ingredient along with 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.
Typically, the concentration of the biologically active ingredients, pharmaceutically acceptable parent base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof is in the range of about l0mg/ml to about l00mg/ ml.
Typically, the injectable preparation in accordance with this invention comprises 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 with or without addition of preservative substance.
Typically, the preservative is at least one preservative selected from a group of preservatives consisting of benzalkonium chloride, chlorocresol and phenyl mercuric nitrite. The pH of solution is maintained within a specified range.


The invention also provides method of preparation of an injectable sterile solution containing pharmaceutically acceptable parent base substance 3-Hydroxy-2, 4, 6-trimethylpyridine and/or derivative and/or salt thereof, in the range of about l0mg/ml to about l00mg/ ml.
The formulated product is adjusted to required pH range with buffer, alkali or acid solutions. The sterile injectable preparation in accordance with this invention contains 3-Hydroxy-2,4,6-trimethylpyridine or its water soluble derivative or salt thereof in the range up to l%w/v or preferably up to 10% w/v in water for injection, along with preservatives such as benzalkonium chloride as required and pH adjusted with buffer, alkali or acid in slight acidic range. The entire process is carried out under inert gas environment. The resultant dosage form solution is sterilized either by sterile filtration or by autoclaving and then filled in ampoules, vials or other such containers used for sterile pharmaceutical preparations.
The injectable preparation in accordance with this invention is stable under specified storage condition and meets various physico-chemical and microbiological standards of specification as per pharmacopoeal requirements.
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 illustrative of the invention and not as a limitation.