FORM 2
THE PATENTS ACT 1970 (Act 39 of 1970)
COMPLETE SPECIFICATION
(SECTION 10)
ADMINISTERING INCOMPATIBLE ACTIVES USING COMPARTMENTAL
UNIT DEVICE.
Glenmark Pharmaceuticals Limited, an Indian Company,
registered under the Indian company's Act 1957 and
having its registered office at
B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road
Post Box No. 26511
Mumbai - 400 026, India
THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THE INVENTION

FIELD OF THE INVENTION
This invention relates to a multi-compartment container system and assembly for separately storing two or more components in individual containers until ready for combining and mixing prior to use. This invention further relates to a multi-compartment container that may be used to dispense a predetermined amount of the content of the multi-compartment container.
BACKGROUND OF THE INVENTION
The global market for combination products is expanding and the driving force is definitely from the medical device industry. There is always a need of Combination preparations of two or more actives which play an important role in clinical treatment because of its better and wider curative synergism and weaker side effects. However, the existence of incompatibility between active ingredients or between active ingredients and excipients presents a serious obstacle in the preparation of such combination dosage forms. But many times these drugs are found incompatible with one another and thus results into unacceptable final stability of the composition and makes it difficult to use these drugs in combination.
When drugs are incompatible, one alters the action of the other as well as certain foods, vitamins and herbal supplements also can change the way a medication works. One drug may boost the action of another, in essence causing an overdose. Or, it may reduce or neutralize the second drug's effectiveness by interfering with its processing by the body. Some drug combinations are highly toxic, even fatal.e.g. Clindamycin ointment is found to be incompatible with Benzyl Peroxide ointment. Clindamycin is an effective antibacterial and Benzyl Peroxide is Keratolytic agents. Both these ingredients used in combination are found to be effective for the treatment of acne treatment. But due to their incompatibility with one another there was difficulty in formulating them together. But the container disclosed in this embodiment solves the problem of administration of the two compositions
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together by formulating two formulations separately and filling them in separate compartments of the container. During the time of application, on squeezing the container both these ointments comes out through the common nozzle or through separate nozzles in required therapeutic concentrations and they are mixed manually before the use and are applied. The packaged container is for one time use only.
This container is suitable for administration of any such two or more therapeutic active components which are incompatible with one another but needs to be given in therapeutic combination. This model can be modified to administer even the powder, solution or any other dosage form well known in pharmaceutical art. The inner compartments can be modified to administer more than two incompatible actives simultaneously without coming in contact with each other before use.
A multi-compartment container assemblies are known in the art where two or more individually sealable assembly units may be joined together to assemble a multicompartment container. One concern with such multi-compartment container assemblies is that at least one of the assembly units must be unsealed before other sealed assembly units can be attached to it to form a multi-compartment container. Removing the seals during the assembly process introduce a potential risk of contaminating or spilling the contents of the assembly units.
A container assembly system for storing multiple components of a formulation in separate individual container assembly units is already disclosed in the PCT application Number WO 03/ 013960 (Applicant: M LI S PROJECTS LTD) that can be assembled easily into a single multi-compartment container. The components of a formulation may be stored in each assembly units and then assembled into a multi-compartment container so that the components can be mixed into a formulation just prior to use. The assembly units, each containing a component of a formulation, can also be assembled into a single multicompartment container first and then stored until ready for use. But this multicompartment system is found very complicated to assemble. Due to the uneasiness in the handling the utility is restrictive.
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US 6448223 patent assigned to Cosmoferm claims "A dispensing system for benzoyl peroxide and an antimicrobial agent which antimicrobial agent is a macrolide or an aminoglycoside antibiotic, wherein said dispensing system comprises a first container containing a first composition consisting essentially of benzoyl peroxide suspended in an aqueous medium and further including a viscosifying agent, and a second container containing a second composition, said second composition consisting essentially of said antimicrobial agent in a solvent wherein said solvent is present in a concentration which is too high for direct topical application, and a viscosifying agent." This dispenser combines in one housing and fitted with an air free pump, both activated by the same actuator. The assembly claimed in this patent is complicated form manufacturing and utility point of view.
Also, US 20030044432 claims "A package comprising components which, upon being mixed, are capable of forming a pharmaceutical composition that is effective in treating acne, said composition tending to degrade prematurely, one of said components comprising an oxidizing agent and another of said components comprising an antibiotic which is effective against acne-associated bacterial species, said components separated one from the other in said package, said one component having a viscosity within about 50% of the viscosity of said other component. "Further 442 application discloses is a package comprising components having two different compartments and having two different nozzles. The container in this application is not able to deliver the complete therapeutic dose of the drug and needs to be thrown away with the drug remain inside.
Present invention is a unit medical device with a multi compartmental system in which the incompatible drugs are placed in different compartments. The container is squeezable and on squeezing it dispenses the medicines in required quantity which are meant tobe mixed just before the application. Due to the divided compartmental system, the therapeutically effective active are not in contact with one another and thus solves the problem of incompatibility and increases the chances of efficient therapeutic benefits. The device is useful when the medicaments are required to be incorporated in the form of semisolids or
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any other suitable dosage form. The material of the container of this invention is such that it ensures the complete transfer of the complete therapeutical dose of the drugs and the container is a single use container and needs to be discarded after use.
SUMMARY OF THE INVENTION
Thus, it is an object of the present invention to provide a multicompartment device and method for dispensing the dosage forms.
It is an object of further embodiments of the present invention to provide a container and method that prevents misuse of the medicament within the dosage form by not dispensing unrequired dosage form unless it is not dispensed from the device by squeezing.
In accordance with a currently preferred exemplary embodiment the container and method includes a container for dispensing the drug that are incompatible with one another and needs to be mixed just before the administration.
It is an object of further embodiments it has a first compartment and a second compartment. The first compartment and the second compartment have common outlet/different outlets of a sufficient size to dispense two dosages. The unit device is having a partition(s) inside that separates the two drugs from each other. Thus the drug are not in contact with each other and thus avoids the problem of incompatibility.
In accordance with another currently preferred exemplary embodiment the container and method includes providing a patient with therapeutically effective and required quantity of actives in required concentration.
In accordance with another currently preferred exemplary embodiment the container and method includes a device for the regulated dispensing of medication including a container having a first compartment and a second compartment. Flexibility of the tube regulates the
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dispensing of the medicament in require proportion. The first compartment comprises a used dosage form outlet that is unidirectional.
The multicompartment container is made up of material such as polypropylene-aluminium-polypropylene.
The multicompartment container is most preferably made up of 12 micron polypropylene-12 micron aluminium-150 gauge polypropylene.
The pouch provided to the patient may be a compartmentalized dispenser, such as that described above or any other disposal and dispensing system for drug delivery of incompatible. The example of administration of such incompatible drug is a combination product of benzoyl peroxide gel & clindamycin phosphate gel. For the therapeutic effect this combination is well known, but the drugs are found to be incompatible with each other and so required tobe administered separately. The device described herein in this specification having two/more than two compartments are suitable to pack two drugs separately and is possible to administered two drugs simultaneously just before use.
BRIEF DESCRIPTION OF THE FIGURES
The above and still further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments therefor, especially when taken in conjunction with the accompanying drawings wherein the reference figures are utilized to designate components, and wherein:
FIG. 1 is a perspective view of a two-compartment container assembly according to an embodiment of the invention;
In which (1) is 1st product compartment. (2) is 2nd product compartment, 3rd is the nozzle and (4) is the base of the container so that it can also stand in upright position.
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DETAILED DESCRIPTION OF THE INVENTION
Referring now to FIGS. 1, a system administering two incompatible active dosage forms and dispensing require dosage forms in accordance with the present invention is illustrated. The system includes a container having a first compartment (1) and a second compartment (2). First compartment (1) has first active and second compartment (2) is containing second active. The two compartments are having a common outlet (3) or separate outlet and a flat base so that the container can stand in upright position. The container is made up of flexible material that makes the container squeezable in nature.
Two or more compartment containers for medicinal formulations, dietary powders to be reconstituted with a liquid, alcoholic beverages to form cocktails with other ingredients or various non-alcoholic beverages that are prepared from powders wherein one compartment contains one component and the other compartment contains another component to be mixed to form a formulation. The multi-compartment containers may also be used to store a quantity of a substance to be dispensed in a predetermined desired quantities The unit compartmental device may be two compartmental or multi compartmental in nature. The container delivers the complete therapeutic dose of the drug and the container needs tobe discarded after use as it is a single use container.
Since the two drugs are filled in separate compartments in the present invention. The below mentioned are the example for preparation of Benzoyl peroxide gel and Clindamycine gel.
BENZOYL PEROXIDE GEL USP & CLINDAMYCIN PHOSPHATE GEL USP
(2.5% & 1%)
EXAMPLE 1
BENZOYL PEROXIDE GEL USP 2.5% w/w

Sr.No. INGREDIENTS STANDARD UNIT QUANTITY IN %
I Purified Water 81.000
Colloidal Silicon Dioxide 0.100
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(Aerosil)
Carbomer 940 (Carbopol 940) 1.000
II Purified Water 10.000
Methylparaben 0.200
Propylparaben 0.020
Disodium Ededate 0.100
III Glycerin 4.000
Poloxamer 182 (Pluronic L-62) 0.100
Dimethicone 350 0.100
Disodium LaurylSulfosuccinate( TEXAPON SB3KC) 0.040
IV Purified Water 2.000
Sodium Hydroxide 0.250
V Hydrous BenzoylPeroxideEq. to AnhydrousBenzoyl Peroxide 4.038
Poloxamer 182 (Pluronic L-62) 0.100
Manufacturing Process:
PREPARATION OF CARBOL PHASE
In 100 litres stainless steel (SS) tank added purified water. Dispersed slowly for about 25-30 minutes in small portions under stirring Colloidal Silicon Dioxide and Carbomer 940 (Carbopol 940). After the addition completed the mixture was stirred for 10 minutes. Carbomer phase was transferred to ointment manufacturing Plant (OMP), and rinsed with 8 kg purified water and after keeping aside for few minutes heated to 70°C to 72°C.
PARABEN AND DISODIUM EDETATE PHASE
In 10 litre stainless steel tank add purified water. Heated up to 70°C to 72°C with the help of steam coil and added under stirring methylparaben, propylparaben and Disodium Edetate. The stirring was continued for 5 minutes to dissolve completely and then added to
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to the above mix at 70°C under stirring. The mix was allowed to soak for 1 hour and cooled down to 40°C assuring that no lumps are formed.
PREPARATION AND ADDITION OF GLYCERIN PHASE
In 10 litre ss tank added Glycerin, Poloxamer 182 (Pluronic L -62), Dimethicone 350 and Disodium Lauryl Sulfosuccinate ( TEXAPON SB 3KC). Stirred for a minute to mix uniformly and added to OMP under stirring, and continued stirring for 10 minutes to mix uniformly.
PREPARATION AND ADDITION OF SODIUM HYDROXIDE SOLUTION
In 5 litre ss container added purified water, add sodium hydroxide. Stirred with ss spatula to dissolve completely. Added slowly under stirring to manufacturing vessel
MIXING AFTER ADDITION OF SODIUM HYDROXIDE SOLUTION
Continued stirring for 20 minutes at slow speed (18 rpm) to form white gel.
ADDITION OF POLOXAMER 182 AND GELTO HYDROUS BENZOYL PEROXIDE
Added to Hydrous Benzoyl Peroxide, Poloxamer 182 ((Pluronic L-62) and Mixed for 5 minutes with ss spatula and mixed to form a uniform paste.
MILLING THROUGH TRIPLE ROLLER MILL
Passed the paste through triple roller mill twice. After milling twice, if particles are observed again pass through triple roller mill .Rinsed the triple roller mill with 2 kg purified water.
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MIXING
Added triple rolled paste to manufacturing vessel. Mixed the Bulk for 60 minutes at slow speed under vacuum and check the pH (Limit 5.0 to 7.0 ).Unload the Gel in tarred SS tanks using Scoop. Covered the tanks with lid.
CLINDAMYCIN PHOSPHATE GEL USP l%w/w

Sr. No. INGREDIENTS STANDARD UNITQUANTITY IN %
I Purified Water 62.000
Disodium Ededate 0.050
Carbomer 940 (Carbopol 940) 0.600
II Macrogol 400 (PEG 400) 10.000
III Propylene Glycol 5.000
Methylparaben 0.200
Propylparaben 0.020
IV Purified Water 2.000
Sodium Hydroxide 0.100
V Purified Water 18.000
Clindamycin Phosphate equivalent to Clindamycin 1.474
Purified Water(rinsing) 2.000
Manufacturing Process:
PREPARATION OF CARBOMER PHASE
In 100 litre SS tank added purified water, to which then added under stirring to dissolve Disodium Edetate. Dispersed slowly for about 25 to 30 minutes in small portions under stirring Carbomer 940 (Carbopol 940).After complete addition, stirred for 10 minutes. Transfered to Ointment manufacturing Plant (OMP) and allowed it to soak for 1 hour
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ADDITION OF MACROGOL 400 (PEG 400)
Added under stirring to manufacturing vessel, macrogol 400 (PEG 400) PREPARATION ADDITON OF PARABEN PHASE
In 10 litre ss container added propylene glycol. Heated up to 60°C to 62°C, added Methylparaben and Propylparaben .Stirred with ss spatula to dissolve completely .Added under stirring to manufacturing vessel.
PREPARATION AND ADDITION OF SODIUM HYDROXIDE SOLUTION
In 5 litre ss container add purified Water, add Sodium Hydroxide. Stir with ss spatula to dissolve completely . Add slowly under stirring to manufacturing vessel
MIXING AFTER ADDITION OF SODIUM HYDROXIDE SOLUTION
Stirring was continued for 20 minutes at slow speed (18 rpm) to form clear transparent gel
PREPARATION AND ADDITION OF CLINDAMYCIN PHOSPHATE SOLUTION
In 25.0 litre SS tank added purified water, added slowly in small portion under stirring using lab. Stirred Clindamycin Phosphate. Continued stirring for 10 minutes to form clear solution and added slowly under stirring to manufacturing vessel and , rinse the container with purified water.
MIXING
Mixed the Bulk for 25 minutes at slow speed (18 rpm) under vacuum and Check the pH (Limit 4.0 to 7.0).
Unload the Gel in tarred SS tanks using scoop. Cover the tanks with lid.
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EXAMPLE 2
BENZOYL PEROXIDE GEL USP 5% w/w

Sr. No. INGREDIENTS STANDARD UNIT QUANTITY IN%
I Purified Water 77.000
Colloidal SiliconDioxide(Aerosil) 0.100
Carbomer 940 (Carbopol 940) 1.400
II Purified Water 10.000
Methylparaben 0.200
Propylparaben 0.020
Disodium Ededate 0.100
III Glycerin 4.000
Poloxamer 182 (Pluronic L-62) 0.100
Dimethicone 350 0.100
Disodium LaurylSulfosuccinate(TEXAPON SB 3KC) 0.040
IV Purified Water 2.000
Sodium Hydroxide 0.290
V Hydrous BenzoylPeroxideEq. to AnhydrousBenzoyl Peroxide 8.076
Poloxamer 182 (Pluronic L-62) 0.100
Manufacturing Process:
PREPARATION OF CARBOL PHASE
In 100 litres stainless steel (SS) tank added purified water. Dispersed slowly for about 25-30 minutes in small portions under stirring Colloidal Silicon Dioxide and Carbomer 940 (Carbopol 940). After the addition completed the mixture was stirred for 10 minutes.
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Carbomer phase was transferred to ointment manufacturing Plant (OMP), and rinsed with 8 kg purified water and after keeping aside for few minutes heated to 70°C to 72°C.
PARABEN AND DISODIUM EDETATE PHASE
In 10 litre stainless steel tank add purified water . Heated up to 70°C to 72°C with the help of steam coil and added under stirring methylparaben, Propylparaben and disodium Edetate. The stirring was continued for 5 minutes to dissolve completely and then added to to the above mix at 70°C under stirring. The mix was allowed to soak for 1 hour and cooled down to 40°C assuring that no lumps are formed.
PREPARATION AND ADDITION OF GLYCERIN PHASE
In 10 litre ss tank added Glycerin, Poloxamer 182 (Pluronic L -62), Dimethicone 350 and Disodium Lauryl Sulfosuccinate ( TEXAPON SB 3KC). Stirred for a minute to mix uniformly and added to OMP under stirring, and continued stirring for 10 minutes to mix uniformly.
PREPARATION AND ADDITION OF SODIUM HYDROXIDE SOLUTION
In 5 litre ss container added purified water, add sodium hydroxide. Stirred with ss spatula to dissolve completely. Added slowly under stirring to manufacturing vessel
MIXING AFTER ADDITION OF SODIUM HYDROXIDE SOLUTION
Continued stirring for 20 minutes at slow speed (18 rpm) to form white gel.
ADDITION OF POLOXAMER 182 AND GELTO HYDROUS BENZOYL PEROXIDE
Added to Hydrous Benzoyl Peroxide, Poloxamer 182 ((Pluronic L-62) and Mixed for 5 minutes with ss spatula and mixed to form a uniform paste.
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MILLING THROUGH TRIPLE ROLLER MILL
Passed the paste through triple roller mill twice. After milling twice, if particles are observed again pass through triple roller mill .Rinsed the triple roller mill with 2 kg purified water.
MIXING
Added triple rolled paste to manufacturing vessel. Mixed the Bulk for 60 minutes at slow speed under vacuum and check the pH (Limit 5.0 to 7.0).Unload the Gel in tarred SS tanks using Scoop. Covered the tanks with lid.
CLINDAMYCIN PHOSPHATE GEL USP l%w/w

Sr. No. INGREDIENTS STANDARD UNITQUANTITY IN %
I Purified Water 62.000
Disodium Ededate 0.050
Carbomer 940 (Carbopol 940) 0.600
II Macrogol 400 (PEG 400) 10.000
III Propylene Glycol 5.000
Methylparaben 0.200
Propylparaben 0.020
IV Purified Water 2.000
Sodium Hydroxide 0.100
V Purified Water 18.000
Clindamycin Phosphate equivalent to Clindamycin 1.474
Purified Water(rinsing) 2.000
Manufacturing Process:
PREPARATION OF CARBOMER PHASE
In 100 litre SS tank added purified water, to which then added under stirring to dissolve Disodium Edetate. Dispersed slowly for about 25 to 30 minutes in small portions under
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stirring Carbomer 940 (Carbopol 940). After complete addition, stirred for 10
minutes. Transfered to Ointment manufacturing Plant (OMP) and allowed it to soak for 1 hour
ADDITION OF MACROGOL 400 (PEG 400)
Added under stirring to manufacturing vessel, Macrogol 400 (PEG 400) PREPARATION ADDITON OF PARABEN PHASE
In 10 litre ss container added propylene glycol. Heated up to 60°C to 62°C, added Methylparaben and Propylparaben .Stirred with ss spatula to dissolve completely .Added under stirring to manufacturing vessel.
PREPARATION AND ADDITION OF SODIUM HYDROXIDE SOLUTION
In 5 litre ss container add purified Water, add Sodium Hydroxide. Stir with ss spatula to dissolve completely . Add slowly under stirring to manufacturing vessel
MIXING AFTER ADDITION OF SODIUM HYDROXIDE SOLUTION
Stirring was continued for 20 minutes at slow speed (18 rpm) to form clear transparent gel PREPARATION AND ADDITION OF CLINDAMYCIN PHOSPHATE SOLUTION
In 25.0 litre SS tank added purified water, added slowly in small portion under stirring using lab. Stirred Clindamycin Phosphate. Continued stirring for 10 minutes to form clear solution and added slowly under stirring to manufacturing vessel and, rinse the container with purified water.
MIXING
Mixed the Bulk for 25 minutes at slow speed (18 rpm) under vacuum and Check the pH (Limit 4.0 to 7.0).
Unload the Gel in tarred SS tanks using scoop. Cover the tanks with lid.
In practice, after quizzing the container the actives from the respective compartment gets dispensed in required quantity they are manually require to be mixed before application. This pack is being developed to fulfill the requirement of dispensing equal
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quantities together at the time of This device is more suitable to dispense the drug in the form of semisolid state and the drugs require to be applied are having synergistic effect to be applied together at the same time they are incompatible to each other . Thus device solves the problem of dispensing therapeutically effective incompatible drugs in combination using unit device with multicompartment system.
The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and the accompanying figures. Such modifications are intended to fall within the scope of the appended claims.
Dated this twenty seventh (27th), day of September, 2006
Taranpreet Lamba.
(Sr. Manager-IPM)
Glenmark Pharmaceuticals Limited
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Claims:
1. A multicompartment medicament container comprising two separate compartments to fill two different medicaments and the container having a single/separate nozzle.
2. A multicompartment medicament container as claimed in claim 1, is meant for a single use purpose.
3. A multicompartment medicament container as claimed in claim 1, may have a single or separate nozzle.
4. A multicompartment container as claimed in claim 1, is made up of flexible material in which inner surface is laminated so that complete therapeutic dose of drugs is delivered.
5. A multicompartment container as claimed in claim 1 and 2, is filled with the material either in semi-solid state or liquid state or in the form of powder or mixture thereof.

6. A multicompartment container as claimed in claim 3, is made up of material such as polypropylene and aluminium foil.
7. A multicompartment container as claimed in claim 3, the inner surface of the container is laminated with the material such as
8. The multicompartment container as claimed in claim 1 and claim 2, comprising two separate compartments suitable to deliver two different drugs simultaneously, which drugs are incompatible with one another.
9. The multicompartment container as claimed in claim 1 and claim 8 , comprising two separate compartments suitable to deliver two different drugs simultaneously that are incompatible with one another such as benzoyl peroxide gel and Clindamycin gel.
Dated this twenty seventh (27th) day of September, 2006

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ABSTRACT
This invention relates to a multi-compartment container system and assembly for separately storing two or more components in individual containers until ready for combining and mixing prior to use. This invention further relates to a multi-compartment container that may be used to dispense a predetermined amount of the content of the multi-compartment container. This container may have a common single nozzle/two or more separate nozzles.

Dated this Twenty seventh (27,n) day of September, 2006

Taranpreet Lamba.
(Sr. Manager-IPM)
Glenmark Pharmaceuticals Limited