Title of Invention	PROCESS FOR PREPARATION OF WATER DISPERSIBLE TABLET
Abstract	This invention relates to a water dispersible formulation of an active pharmaceutical ingredient or pharmaceutically acceptable slat hereof and one or more adjuvants without the use of swellable clay. More particularly, the invention comprises a dispersible formulation of anti-epileptic drug-lamotrigine. This invention further relates to a process for the preparation of said formulation.

Full Text

FORM 2 THE PATENTS ACT, 1970 {39 Of 1970) COMPLETE SPECIFICATION (See Section 10) RESPIRATORY THERAPY DEVICE FOR KEEPING FREE THE NATURAL RESPIRATORY TRACT OF A HUMAN BODY AND THE USE THEREOF IN ORDER TO PREVENT THE SOUND OF SNORING HOFFRICHTER MEDIZINTECHNIK GMBH of METTENHEIMER STRASSE 12/14, 19061 SCHWERIN, GERMANY, GERMAN Company The following specification particularly describes the nature of the invention and the manner in which it is to be performed : - 1 he invention deals with a procedure in accordance with the generic term ot Claim 1 and a respirator;" therapy device in accordance with the generic term ot Claim 2. Such devices are used for the treatment ol obstructhe sleep apnoea. Another application is the prevention of snoring. Known for use in respiratory therapy are so-called CPAP devices (CPAP = Continuous Positive Airway Pressure) for the generating ol a positive airua\ pressure. These devices make air for breathing available in a lace mask, with the pressure of the air being constantly higher than the atmospheru pressure by a tew hPa. When a patient is breathing in this artificial atmosphere, (he positive relative pressure keeps his respiratory system extended wide enough. 1 Thus a CPAP device only effects a pneumatic splinting" of the respiratory system. I he breathing process itself is based solely on the user"s own respiration. Snoring is an indication of a relaxed and narrow respiratory system. In the case " of a high flow rate through the pharynx the air pressure will drop there, because the distance between the air molecules becomes greater with the increased speed. As a result the relaxed tissue "collapses in that area and complete!1, blocks the air path. Due to the blockage the negative pressure caused by the tiow rate disappears, the respiratory system rears up again and the air will again flow until it reaches a certain speed. This will then immediateb lead to the next blockage. 1 he sound of snoring is caused bv. the quick sequente of the blocking and opening of the respiratory system. A CPAP device increase- the air pressure in comparison with the atmospheric standard pressure (relative pressure) to the extent that the reduction in pressure caused bv the flow rate car. St) longer effect a blockage and thus prevents the creation ol the sound of snorinc, Respiratory therapy device for keeping the upper respiratory s\ stem ol a human being open via an air pressure splint, consisting ot a pressure-resistant hollow bodv, which surrounds the human body while keeping the natural breathing opening free and which at least in the extra-corporeal region of the respirator; svstem forms a Negative Pressure Chamber (7), whoreb\ the Negative Pressure Chamber (7} is connected to a Suction Pump (A) via a Suction Iube [2); wherein the pressure resistant hollow bodv is designed as a Cap (I), the edge ot which runs around the frontal neck region, starting from the chin, along both sides of the lower jaw, the sides of the neck and the region of the collarbone to the upper end of the sternum and is designed in such way it covers the area ot skin surrounded bv its edge like a copula, while maintaining a distance to the skin. When the mechanism that forms the basis of snoring exceeds a certain degree ot sevoritv, then the respiratory drive may tail. This, constitutes the disease Obstructive Sleep Apnoea, which requires treatment and which affects at least I "o of the population. The disease is mainly treated with CPAP devices. Mechanical aids or surgical treatment are further possible therapies, but ihese ,\rv ot less importance. A disadvantage of known CPAP devices is that they have an internal Mow resistance, which the patient has to overcome with his respiratoi \ muscles. i his results in additional work, because the internal resistance of the device is added to the resistance of the respiratory system ot the patient. Another disadvantage is that the air is warmed when passing through the de\ ice\ that therefore its relative humidity is reduced. conseejuentU the airand dehvdrates the mucous membranes. As drv mucous membranes are not only uncomfortable, but also loose their defensive function, it becomes necessan to humidify the air in" connection with respiratory thereby. Therefore CPAP de\ ices are equipped with an integrated air humidifier or the air humidifier is installed as additional device between the CPAP device and the patient. Further disadvantages of CPAP devices are operating noises, impediments due to the facemask, hygienic risks and high energy consumption. Therefore the invention is based on the task to create a generic procedure and a corresponding respiratory therapy device, which allows breathing in tree atmosphere. Further tasks are the abolition of the facemask, the reduction of" the operating noise, the improvement of hygiene andi the reduction of the energ\ consumption. On the side of the process this task is solved by the characterising features of Claim 1 and on the side of the device by the characterising features ot Claim 2. Advantageous design possibilities of the respiratory therapy device be found in the Dependent Claims 3 - 6. The invention removes the disadvantages of the state of technology. By bringing the entire body or preferably only parts ot the bod\ . lor example the soft front region of the neck, into a chamber, which has a reduced relative pressure, the collapse of the respiratory system is the area on the pharnwn is prevented, because in that case the higher static pressure ot the standard atmosphere is the splinting the respiratory s\ stem. In the ph\sical sense this process is a reversal of the OPAP principle that is known from the state ot technology. In that way the patient is able to breath in standard atmosphere and has the advantage that the troublesome breathing mask is no longer necessan . As the inhaled air does no; have to flow through technical components, there is no additional respir"9tory resistance and the respiratory muscles are not subjected to an additional load. The inhaling of standard atmosphere also makes the additional humidifying of the air unnecessary and the expense and work ot the air humidifier is no longer necessary. Respiratory therapy device for keeping the upper respiratory system of a human being open via an air pressure splint, consisting ol a pressure-resistant hollow bod\, which surrounds the human body while keeping the natural breathing 4 opening tree and which at least in the extra-corporeal region of the respirators" system forms a Negative Pressure Chamber (7), whereby the Negative Pressure Chamber (7) is connected to a Suction Pump (3) via a Suction tube (2); the pressure resistant hollow body is designed as a Cap (1), the edge of which runs around the frontal neck region, starting from the chin, along both sides ot the lower jaw, the sides of the neck and the region of the collarbone to the upper and of the sternum and is designed in such wav it covers the area of skin surrounded bv its edge like a copula, while maintaining a distance to the skin. As the respiratory therapv device in accordance with the invention no longer has to supply the air for breathing, but only has to maintain the negative relative pressure in a chamber, the breathing tube can be replaced bv a thin suction tube. However, the air suction ventilator doe not have to move large quantities ot air, but only the quantity, which flows into the negative pressure space due to leakages. 1 he required output of the suction ventilator can, thus be small and can also be supplied bv a batterv. In addition, the overall device can be kept quite small, which makes good sound insulation possible. There are also advantages in the area of safety. A failure of the ventilator docs not automatically lead to the rebreathing ot CO:. In a case like that the symptoms ol obstructive sleep apnoea would occur again, but that is all that could happen. There are advantages with regard to hygiene, because the inhaled air does not flow through accessory parts such as tube and mask and thus there is no formation ot condensation water. That means that the cleaning, cycle can be extended significantly. The utilization of the device bv different patients is safe. As the design of the device is simple and its production inexpensive and because there is no risk involved in its use, it also can be used without a doctor"s prescription, e.g. in order to prevent snoring. Devices known tor that consist 5 mostly of an object that has to be carried in the mouth or on the teeth I his can easily lead to accidents, tor example, when the anti-snoring clasp used conies loose and is swallowed. The invention is to be explained in greater detail using the application example in the following. The accompanying figure shows the structure of easily realised possibility. The sample device consists oi a Neck Mask 1, a Suction tube 2 a Suction Pump 3. The Neck Mask 1 is a half-open chamber, which spans the front (ventral) neck, region like a copula. The edge oi the Neck Mask 1 runs around the region, starting from the chin, along both sides oi the lower jaw to the sides" of the neck and from there continues to the front downwards to the upper end of the sternum. Along the edge a Sealing Device 6 is arranged, which lies on the skin when in use. In this way the open side ot the Neck Mask 1 is closed oft bv the skin of the patient and a closed Chamber Volume. 7 is created. The surface of the neck mask is designed in such wav thai it is rigid in perpendicular direction to its surface, but flexible in the expansion direction oi the surface. Due to this feature the surface of the mask is able to expand and contract during nodding movements of the head L-[\\d deform sideways in the case of turning movements of the head. In this example this characteristic is achieved bv the fact that the covering oi the Neck Mask I consists of an Plastic Shin 5, tor example rubber or another elastomer, over a sub-structure ot stabilising Skeleton Stays 4. At a suitable point, preferably in the lower region of the Neck Mask 1, the Air Outlet 8 is arranged in the form ot a connection piece, which leads from the outside through the covering of the Neck Mask 1 into the closed Chamber Volume 7 and via the Suction Tube 2 is connected to the suction side ot the Suction Pump 3. A Neck Band 9 is provided for the wearing and stabilisation of the correct tit ot the Neck Mask 1, which could also be equipped with a closing device preferably 6 with a Velcro closing band. Via the Suction Tube 2, which is connected to the Air Outlet S, the Suction Tump 3 creates a constant negative pressure of a few hPa in the closed Chamber Volume 7 during use. This is achieved bv a pressure-regulated suction pump or bv setting a particular rpm on the suction ventilator. When leakages occur between the skin of the patient and the Sealing Device 6, the leakage volume entering the closed Chamber Volume 7 is sucked oft. either do head movements cause a change in the negative pressure of the closed Chamber Volume 7, it the Suction Pump 3 or the used suction ventilator hav4 a device for regulating the pressure. As the Neck Mask 1 covers the entire ventral neck region and at this point is creating an artificial negative pressure atmosphere using the closed Chamber Volume 7, the respiratory system of the patient is splinted bv the pressure of the standard atmosphere. A drop in pressure that is caused by the flow in the pharynx of the patient do no longer lead to a collapse ot the respirator\ system. Snoring noise can no longer be generated. Patients with obstructive sleep apnoea can breath freely and again enjov a healthy sleep. 7 CLAIM : 1. Procedure for keeping the upper respiratory system of a human being open via an air pressure splint, wherein the respiratory system is exposed to the pressure of the atmosphere and that the extra-corporeal area of the respiratory system is exposed to an artificial negative pressure, whereby the difference between the internal atmospheric pressure and the external negative pressure is kept constant. 2. Respiratory therapy device, wherein a pressure-resistant hollow body, which surrounds the human body while keeping the natural breathing opening free and which at least in the extra-corporeal region of the respiratory system forms a Negative Pressure Chamber (7), whereby the Negative Pressure Chamber (7) is connected to a Suction Pump (3) via a Suction Tube (2). 3. Respiratory therapy device as claimed in Claim 2, wherein the pressure resistant hollow body is designed as a Cap (1), the edge of which runs around the frontal neck region, starting from the chin, along both sides of the lower jaw, the sides of the neck and the region of the collarbone to the upper end of the sternum and is designed in such way it covers the area of skin surrounded by its edge like a copula, while maintaining a distance to the skin. 4. Respiratory therapy device in as claimed in Claim 3, wherein the fact that the Pressure-resistant Cap (1) is made of a material, which is stable in perpendicular direction to the body surface and in the direction of the surface is so flexible that it allows movements of the head. 9 5. Respiratory therapy device in as claimed in Claim 4, wherein the fact that the Pressure-resistant Cap (1) is constructed of a preferably integrated sub-structure made of stabilising Skeleton Stays (4) and an elastic Skin 5 lying on top of it, for example made of rubber or another elastomer. 6. Respiratory therapy device in as claimed in Claim 1, wherein the fact that the Suction Pump (3) is equipped with a pressure-regulating device for generating and maintaining a negative pressure that can be pre-selected. Dated this 12th day of December, 2003. HIRAL CHANDRAKANT JOSHI AGENT FOR HOFFRICHTER MEDIZINTECHNIK GMBH 10

Documents:

1128-mum-2003-abstract(28-10-2003).pdf

1128-mum-2003-abstract(amended)-(27-4-2004).pdf

1128-mum-2003-abstract(granted)-(22-1-2008).doc

1128-mum-2003-abstract(granted)-(22-1-2008).pdf

1128-mum-2003-cancelled pages(27-4-2004).pdf

1128-mum-2003-claims(28-10-2003).doc

1128-mum-2003-claims(28-10-2003).pdf

1128-mum-2003-claims(amended)-(27-4-2004).pdf

1128-mum-2003-claims(granted)-(22-1-2008).doc

1128-mum-2003-claims(granted)-(22-1-2008).pdf

1128-mum-2003-correspondence 1(27-4-2004).pdf

1128-mum-2003-correspondence 2(27-9-2004).pdf

1128-mum-2003-correspondence(ipo)-(31-3-2008).pdf

1128-mum-2003-description(complete)-(28-10-2003).pdf

1128-mum-2003-description(granted)-(22-1-2008).pdf

1128-mum-2003-form 1(28-10-2003).pdf

1128-mum-2003-form 1(6-11-2003).pdf

1128-MUM-2003-FORM 15(03-12-2010).pdf

1128-mum-2003-form 19(7-1-2004).pdf

1128-mum-2003-form 2(28-10-2003).doc

1128-mum-2003-form 2(complete)-(28-10-2003).pdf

1128-mum-2003-form 2(granted)-(22-1-2008).doc

1128-mum-2003-form 2(granted)-(22-1-2008).pdf

1128-mum-2003-form 2(title page)-(complete)-(28-10-2003).pdf

1128-mum-2003-form 2(title page)-(granted)-(22-1-2008).pdf

1128-mum-2003-form 3(28-10-2003).pdf

1128-mum-2003-form 3(6-11-2003).pdf

1128-mum-2003-form 5(6-11-2003).pdf

1128-mum-2003-specification(amended)-(27-4-2004).pdf