FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
PATENTS RULES, 2003
(COMPLETE SPECIFICATION)
TITLE- "AN ORAL PHARMACEUTICAL FORMULATION FOR RESPIRATORY DISEASES."
NAME OF APPLICANT: ZOTA HEALTH CARE LTD
ADDRESS OF APPLICANT ZOTA HEALTH CARE LTD
ZOTA HOUSE,
2/896, HIRA MODI STREET, SAGRAMPURA, SURAT - 395 002 (GUJARAT), INDIA.
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION
The invention is related to pharmaceutical compositions to treat respiratory system disorders. In particular the invention is related to the pharmaceutical compositions to treat chronic obstructive pulmonary disease (COPD), Asthma and other respiratory system disorders.
BACKGROUND OF THE INVENTION
Among the most common airway diseases is asthma. Asthma is generally defined as an inflammatory disorder of the airways with clinical symptoms arising from intermittent airflow obstruction. It is characterized clinically by paroxysms of wheezing, dyspnea and cough. It is a chronic disabling disorder that appears to be increasing in prevalence and severity. It is estimated that 15% of children and 5% of adults in the population of developed countries suffer from asthma. Therapy should therefore be aimed at controlling symptoms so that normal life is possible and at the same time provide basis for treating the underlying inflammation.
COPD is a term which refers to a large group of lung diseases which can interfere with normal breathing. Current clinical guidelines define COPD as a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles and gases. The most important contributory source of such particles and gases, at least in the western world, is tobacco smoke. COPD patients have a variety of symptoms, including cough, shortness of breath, and excessive production of sputum; such symptoms arise from dysfunction of a number of cellular compartments, including neutrophils, macrophages, and epithelial cells. The two most important conditions covered by COPD are chronic bronchitis and emphysema.
Chronic bronchitis is a long-standing inflammation of the bronchi which causes increased production of mucous and other changes. The patientsY symptoms are cough and expectoration of sputum. Chronic bronchitis can lead to more frequent and severe respiratory infections, narrowing and plugging of the bronchi, difficult breathing and disability.
Emphysema is a chronic lung disease which affects the alveoli and/or the ends of the smallest bronchi. The lung loses its elasticity and therefore these areas of the lungs become enlarged. These enlarged areas trap stale air and do not effectively exchange it with fresh air. This results in difficult breathing and may result in insufficient oxygen being delivered to the blood. The predominant symptom in

patients with emphysema is shortness of breath.
Acebrophylline is an airway mucoregulator and anti-inflammatory agent, which is commonly used to treat respiratory system disorders such as acute or chronic bronchitis , chronic obstructive or asthmalike bronchitis, recurrence of chronic bronchitis.
Asthma is a chronic inflammation of the lungs in which the airways (bronchi) are reversibly narrowed. Asthma affects nearly 300 million people worldwide.
United States Patent Application 20090226500 wherein Sutures are used in combination with anti-scarring agents to inhibit fibrosis between the sutures and the host tissues into which the sutures are inserted. Compositions and methods are described for use in reducing excessive scarring, surgical adhesion, and other disorders.
US 7790905 (granted patent)/WIPO Patent Application WO/2004/060347 wherein the invention relates to pharmaceutical compositions comprising propylene glycol solvates of APIs.
US 7927613 (granted patent) wherein A pharmaceutical composition comprising a co-crystal of an API and a co-crystal former; wherein the API has at least one functional group selected from ether, thioether, alcohol, thiol, aldehyde, ketone, thioketone, nitrate ester, phosphate ester, thiophosphate ester, ester, thioester, sulfate ester, carboxylic acid, phosphonic acid, phosphinic acid, sulfonic acid, amide, primary amine, secondary amine, ammonia, tertiary amine, sp2 amine, thiocyanate, cyanamide, oxime, nitrile diazo, organohalide, nitro, s-heterocyclic ring, thiophene, n-heterocyclic ring, pyrrole, o-heterocyclic ring, furan, epoxide, peroxide, hydroxamic acid, imidazole, pyridine and the co-crystal former has at least one functional group selected from amine, amide, pyridine, imidazole, indole, pyrrolidine, carbonyl, carboxyl, hydroxyl, phenol, sulfone, sulfonyl, mercapto and methyl thio, such that the API and co-crystal former are capable of co-crystallizing from a solution phase under crystallization conditions.
Acebrophylline reduces the frequency of episodes of bronchial obstruction, reduces the need for beta2-agonists and improves indexes of ventilatory function. Acebrophylline possesses both muco-regulating and bronchodilator effects thereby showing earlier improvement in signs & symptoms in comparison with Theophylline which has only bronchodilator effects.

The prominent pharmaceutical companies which are involving in the manufacturing of essential phospholipid are Lupin, Sun pharmaceutical, German Remedies, Glenmark, Synokem and Systonic Life sciences thereof. These drugs are available in the market under the trade name such as AB-FLO cap, AB PHYLLINE cap, ACEBROFACT cap, ACIBRO cap, ASCOVENT cap, ASCOVENT syrup, OYLLINE cap thereof.
SUMMARY OF THE INVENTION
One of the main objects of the present invention is to provide a pharmaceutical composition suitable as
treatment against respiratory system disorders and airway diseases.
Airway diseases include Acute Lung Injury, Acute Respiratory Distress Syndrome (ARDS),
occupational lung disease, lung cancer, tuberculosis, fibrosis, pneumoconiosis, pneumonia,
emphysema, Chronic Obstructive Pulmonary Disease (COPD) and asthma.
Another object of the present invention is to provide a pharmaceutical composition that is useful
simultaneously towards chronic obstructive pulmonary disease (COPD) and asthma and which is stable
and palatable over its entire shelf life.
Yet another object of the present invention is to provide a pharmaceutical formulation that reduces the
chance of allergic reaction particularly for COPD and asthma patients.
In accordance with the above object, the present invention provides Easy administration, Economical
oral manufacturing process.
DETAILED DESCRIPTION OF THE INVENTION
The technical subject of the present invention is to provide a useful composition of Acebrophylline and
cetirizine along with the pharmaceutical^ accepted excipients.
The composition of the invention is comprises of active ingredient which typically is essential
phospholipid substance preferably essential phospholipid with the pharmaceutical^ accepted
excipients such as Adsorbent, Binder, Solubilizer, Solvent, Disintegrant, Diluent thereof.
The preferred embodiments are now disclosed. According to the preferred embodiment of the present
invention, there is provided a oral composition for the treatment of Asthma, COPD and respiratory
system disorders. It's use as a bronchodilator and an expectorant in certain respiratory conditions on
humans.

Pharmaceutical Compositions
The active ingredients of the present invention may be administered by oral/Inhaler administration using conventional systemic dosage forms, such as tablets, capsules, pills, powders. The active ingredients may also be administered topically (e.g. to the lung and/or airways) in the form of solutions, suspensions, aerosols and dry powder compositions. These dosage forms will usually include one or more pharmaceutically acceptable ingredients which may be selected, for example, from adjuvants, carriers, binders, lubricants, diluents, stabilising agents, buffering agents, surfactants, preservatives, flavourings and colorants thereof.
In one embodiment of the present invention, the first and second active ingredients of the present invention are each administered by inhalation. In this embodiment, the active ingredients may be inhaled simultaneously (that is, the active ingredients are in admixture). In another embodiment the active ingredients may be inhaled sequentially. Or in a further embodiment the active ingredients may be inhaled separately.
Dry powder inhalers may be used to administer the active ingredients, alone or in combination with a pharmaceutically acceptable carrier, in the later case either as a finely divided powder or as an ordered mixture. The dry powder inhaler may be single dose or multi-dose and may utilize a dry powder or a powder-containing capsule.
Examples of conditions and diseases, which may be treated using the combination of the invention are, but not limited to, airways diseases/respiratory including chronic obstructive pulmonary disease (COPD) such as irreversible COPD; asthma, such as bronchial, allergic, intrinsic, extrinsic and dust asthma, particularly chronic or inveterate asthma (e.g. late asthma and airways hyper-responsiveness); bronchitis; acute, allergic, atrophic rhinitis and chronic rhinitis including rhinitis caseosa, hypertrophic rhinitis, rhinitis purulenta, rhinitis sicca and rhinitis medicamentosa; membranous rhinitis including croupous, fibrinous and pseudomembranous rhinitis and scrofulous rhinitis; seasonal rhinitis including rhinitis nervosa (hay fever) and vasomotor rhinitis; sarcoidosis, farmerYs lung and related diseases, fibroid lung and idiopathic interstitial pneumonia.
The present invention is directed to a composition comprised of an amount of acebrophylline 75mg to 120mg , more preferably in 100 mg wherein Acebrophylline multiple action against the airway diseases, especially chronic obstructive pulmonary disease (COPD) and asthma. These actions are Bronchodilation, Mucoregulation & Anti-inflammatory action.
It acts a mucolytic, to help reduce mucous accumulation and as an anti-inflammatory to help reduce swelling in the airway and improve breathing.

Cetirizine acts as an antihistaminic. It is the fourth addition to a new generation of allergy medications called "non- sedating" antihistamines or histamine (H-l) receptor blockers. These new antihistamines are called non-sedating because they cause less sedation than their predecessors; the other non-sedating antihistamines. Antihistamines block the effects of histamines. Histamines cause symptoms of allergy when released by allergic reactions in the body. Antihistamines block the ability of histamine to promote the allergy symptoms.
The present invention is directed to a composition comprised of an amount of cetirizine preferably 5mg and acebrophyllin used in 100 mg.
The most important advantages of the present invention can be summarized as follows:
1 Easy, administration, Economical oral manufacturing process.
2. Better patient compliance
3. Mucolytic, Mucokinetic, bronchodilator and antihistaminic combination
4. The process according to the invention can be continuously carried out, and allows the large scale preparation of the capsule, tablet, inhaler, granules and mouth melting strip.
Mouth melting strip for this combination is rarely available in the market but its Fast dissolving drug delivery dosage form which offers a solution for those patients having difficulty in swallowing tablets, capsules thereof. The possibility of developing acebrophyllin with cetirizine based fast dissolving strips allowing fast, reproducible drug dissolution in the oral cavity; thus bypassing first pass metabolism.

CLAIMS, We claims,
1. A pharmaceutical oral formulation is comprising acebrophyllin, cetirizine or physiologically acceptable ingredients adsorbent, binder, Solubilizer, solvent, disintegrant thereof.
2. A pharmaceutical oral formulation as claimed as claim 1 wherein pharmaceutical acceptable excipients are selected from the group comprising of a Disintegrant, Diluent thereof.
3. A pharmaceutical oral formulation as claimed as claim 1 wherein acebrophyllin present in the amount of 75mg to 120mg, more preferably in 100 mg.
4. A pharmaceutical oral formulation as claimed as claim 1 wherein cetirizine present in the amount of 4 mg to 7 mg more preferably in 5mg.
5. A pharmaceutical oral formulation as claimed as claim 1 wherein this product will be administrative twice a day.
6. A pharmaceutical oral formulation as claimed as claim 1 wherein it is useful for treatment of airway diseases, especially chronic obstructive pulmonary disease (COPD) and asthma in mammals by administrating said combination.
7. A pharmaceutical oral formulation as claimed as claim 1 wherein it's available in oral dosage form such as tablet, capsule, syrup, inhaler, granules, mouth melting strip thereof.
8. A pharmaceutical oral formulation as claimed as claim 1 wherein it provides Easy administration, Economical oral manufacturing process.