Formulation Evaluation and Comparative Study of Antitussive Tablet with Marketed Formulation

There are many traditional systems of medicine in the world, each with different associated philosophies and cultural origins. Some of these, such as Tibetan traditional medicine, remain relatively localised in their country of origin; while others such as Ayurvedic and Chinese traditional medicines are increasingly used in many different areas of the world. There are many types of drugs that are used to suppress cough and are often prescribed in combination. Before dealing with the particular type of drug used, it is important to consider briefly the nature of cough production, its role in disease and desirability of suppressing it. Cough is a useful physiological mechanism that serves to clear the respiratory passages of foreign material and excess secretions and should not be suppressed indiscriminately7. Cough is thought to be caused by a reflex. It occurs due to stimulation of mechano-or chemoreceptor in throat, respiratory passage or stretch receptor in the lungs8 . The sensitive receptors are located in the bronchial tree, particularly in the junction of the trachea. These receptors can be stimulated mechanically or chemically e.g. by inhalation of various irritants than nerve impulses activate the cough center in the brain Traditionally cough is classified as either productive, i.e. producing mucus usually with expectoration, or nonproductive (dry). Ayurveda is the most widely practised of the Indian traditional medicine systems, but there are others such as Siddha and Unani which are also used in the Indian sub constituent. Herbal medicine is based on the fact that plants contain natural substances that can promote health and alleviate illness. In recent times, focus on plant research has increased all over the world and a large body of evidence has been collected to show immense potential of medicinal plants used in various traditional systems. Traditional Indian system of medicine such as Ayurveda is based on holistic treatment of diseases primarily relying on naturally occurring medicinal substances drug. Most ayurvedic preparations are polyhedral which take care of the multiple components of disease conditions. It is mainly a protective mechanism for the body, occurs whenever any tissues are being damaged, and it causes the individual to remove the pain stimulus. Currently available analgesic drugs such as opiates and NSAI Cough (Tussis) A cough is a natural reflex that is your body?s way of removing irritants from your upper (throat) and lower (lungs) airways. A cough helps your body heal and protect itself. Frequent coughing usually indicates the presence of a disease. Many virus and bacteria benefit, from an evolutionary perspective, by causing the host to cough, which helps to spread the disease to new hosts. A cough in children may be either a normal physiological reflex or due to an underlying cause. In healthy children it may be normal in the absence of any disease to cough ten times a day. In adults with a chronic cough, i.e. a cough longer than 8 weeks, more than 90% of cases are due to post-nasal drip, asthma, eosinophilic bronchitis, and gastroesophegeal reflux Ds are not useful in all cases due to their adverse effects. Types of coughs 1. Dry cough 2. Wet cough 3. Croup cough 4. Paroxysma cough.

Treatment of Cough Based on Herbal Tablet

A cough is a natural reflex that is your body?s way of removing irritants from your upper (throat) and lower (lungs) airway cough can be easily treated by using herbal plants. Because herbal tablet has less side effects as compared to synthetic tablet. Synthetic formulation causes many adverse effects on human body, that?s why now days herbal drugs are mainly used to treat cough. Honey, ginger, turmeric are the most useful agent to treat the cough, and this ingredients are present in this tabet so this tablet mainly used to treat cough. This tablet act as Antitussive. Different parts of the tuisi are used in Ayurveda and Siddha systems of medicine for prevention and cure of many illnesses and everyday ailments like common cold, headache, cough, influenza, earache, fever, colic pain, sore throat, bronchitis, asthma, hepatic diseases, malarial fever. leaves of tulsi contain phytoconstituent which has immemorial activity against cough. Turmeric main ingredient curcuma act against cough.

Review Of Literature

1. Manoj Kumar , Shweta Parihar et al (2022) Cough refers to a powerful explosive expiration thatclears the tracheobronchial tract of fluids and foreign materials. Given the high frequency of coughin both children and adults, the goal of this review paper was to document the plants used to cure and relieve cough in traditional culture and ethnobotany. Medicinal plants have the potential to provide compounds with strong antitussive efficacy and little side effects. Specification of active compounds responsible for therapeutic action, as well as their measurement in healing medications, are recent advancements in modern phytotherapy, allowing for treatment rationalisation, particularly dose and monitoring of unwanted effect.
2. Ojas Patel , Mona Patel et al (2021) Ayurvedic formulations are mainly administered by oral route and most of the orally administered Ayurvedic formulations belong to liquid dosage form of drug or drug combination. However, Herbal products have to fulfil legal requirements with regards to quality including stability testing. Herbal Syrup is commonly used and popular dosage form which is used to cure cough, cold and fever because it having ease of patients compliance. In present study, Prepared Herbal Syrup contain Ginger macerated honey base and also Tulsi
3. Pramod Kumar Manjhi, Sunil Kumar Singh, Chakrapani Kumar*, Akhilesh Kumar Rana et al (2021) Antitussive-expectorants are among the most frequently prescribed drugs by physicians in clinical practice. Upper respiratory tract infections, such as common cold, acute pharyngitis and acute trachea-bronchitis, are the most common of all communicable diseases and significantly increase OPD burden. This study aimed to assess the rational use, cost ratio, and percentage cost variations in different brands of the commonly prescribed antitussive expectorants available in the Indian market.
4. Safia Abidi*, Shahlla Imam, Farhana Tasleem, Syeda Rafia Zehra Rizvi, Sobia Salman, Umer Gilani and Zafar Alam Mahmood. et al (2021) Among respiratory complications, cough is an important defensive pulmonary reflex that removes fluids, irritants or foreign substances from the respiratory tract. Rosa damascene Mill, petal extract is a traditional medicine and reported to use in the management of cough. In the present study rose petals extract samples were used to prepare natural antitussive cough syrups containing ivy leaf extract to observe synergistic effect of rose water in managing coughing in rats.
5. Dr. R. Margret Chandira, Surekha Bharatsingh Barwal et al (2021) In this age of traditional medicine, maintaining quality standards is a matter of time. Current research shows the medicinal functions of Amla (Emblica officinalis), Bharangi (Clerodendrum serratum), Chitrak (Plumbago zeylanica), Kapurkachari (Hedychium spicatum), Kakadshingi (Pistacia integerima), Kantkari (Solanum xanthocarpum), Hirda) (Piper longum), Pushkar roots (Inula racemosa), Bhahava (Cassia fistula), Honey. This article focused on the effects of various drugs on Asthma, cough, upper respiratory tract etc
6. mayuri shitole, pawar vt et al (2019) All over world cough is a common symptom in respiratory disease. When cough becomes severe, opioids act as a potent drug, but they have various side effects such as sedation and constipation. Therefore, there is a necessity to have an effective antitussive formulation, which not revealed respiratory depressant activity. The present study was carried out to analysis the antitussive activity of granules containing Glycyrrhiza glabra L. extract using a cough.
7. Mr. Omkar S. Daware , Dr. Ranajit D. Tijare , Mr Ayush B. Chavhan et al (2018) Diseases in human life are one of the huddle to live life, which consist of chronic and acute diseases. Cough is a common respiratory symptom that can have a significant impact on the quality of life. Polyherbal formulations have been used for centuries in traditional medicine to treat coughs and other respiratory ailments
8. Refaz Ahmad Dar*, Mohd Shahnawaz, Parvaiz Hassan Qazi et al (2017) Medicinal plants have been playing an essential role in the development of human culture. As a source of medicine, Medicinal plants have always been at forefront virtually all cultures of civilizations. Medicinal plants are regarded as rich resources of traditional medicines
9. Shahnaz Sultana*, Andleeb Khan, Mohammed M Safhi And Hassan A. Alhazmi et al (2016) A cough occurs suddenly and often repetitively which helps to clear the large breathing passages from secretions, irritants, foreign particles and microorganisms. Coughing can be due to a respiratory tract infection such as the common cold, acute bronchitis, pneumonia, pertussis, flu and smoking or health problems such as asthma, tuberculosis and lung cancer. Substantial uses of folk remedies for different medical conditions have been documented. The remedies included cinnamon, ginger, clove, cardamom, honey, lemon, garlic, onion, turmeric and licorice.
10. Alyn Morice,1 Peter Kardos2 et al (2016) Acute cough caused by viral respiratory tract infections is probably the most common illness to afflict mankind. Despite the widespread but ineffective prescribing of antibiotics, there is no specific therapy. Home remedies and over-the- counter medicines are the mainstay for treatment of this short-lived but debilitating condition where cough is a major troublesome symptom. Across Europe, there are large variations in the recommendations made by healthcare professionals for the treatment of acute cough. This has arisen through custom and practice based on the evidence of historical studies performed to standards well short of what would be considered legitimate today.
11. Seema Gairola1, Vikas Gupta2 , Parveen Bansal3 , Ranjit Singh1 , Mukesh Maithani et al (2010) The problems emerging from the treatment of cough during many types of respiratory diseases by conventional opioid antitussive agents, such as codeine and codeine-like compounds. Medicinal plants are potential source of substances with high-antitussive efficiency with minimal unwanted effects. Recent trends of modern phytotherapy include specification of active substances responsible for therapeutic effect as well as their quantification in the healing drugs, which enables the treatment rationalization, especially the dosing and pursuing of adverse effects. This review is intended to describe the current status of plant used as antitussive and expectorant and their active compounds with cough-suppressing activity.

Rational Of the Study: -

Need Of Work: -

Herbal preperation are important for their disease preventing and health. Promoting properties Herbal medicines has its origins in ancient culture.it involves the medicinal use of plants to treat disease and enhance gerneral health and wellbeing. Herbal antitussive tablets helps to suppress the urge to cough. Herbal antitussive tablet are natural and free from all the harmful synthetic chemicals that can treat to cough.

Objectives: -

1. To study the Formulation of tablet to treat cough.

2. To show that herbal drugs are more beneficial

3. Formulation of dosage form which have no adverse effect

4. To show the herbal product are economical

5. To understant quality, safety and efficacy of tablet in treatment.

6. The objective of study was to formulate and evaluate antipyretic and antitusive tablet by using wet granulation method

Plan of Work:

• • Selection of pure drug
  • Preparation of reagents-
  • Experimental design-
  • Comparative study
  • Result & discussion
  • Conclusion
  • Reference

Drug profile:

Ginger

Synonym: zingiber, zingiberis, rhizome zingiberis.

Family: Zingiberacea Kingdom: Plantae Order: Zingiberals Species: Z. officinale Genus: Zingiber

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    Fig1. Ginger

Biological Source:

Ginger consists of the dried rhizomes of the Zingiber officinale Roscoe, belonging to family Zingiberaceae.

Geographical Sources:

It is mainly cultivated in West Indies, Nigeria, Jamaica, India, Japan, and Africa.

Cultivation

Ginger plant is a perennial herb that grows to 1 m. It is cultivated at an altitude of 600 to 1,500 m above sea level. The herb grows well in well-drained rich, loamy soil, and in abundant rain fall. The rhizome is cut into pieces called fingers, and each finger consisting of a bud is placed in a hole filled with rotten manure in March or April. The rhizomes get matured in December or January. By January the plants wither after flowering and then the flowers are forked up, buds and the roots removed and washed to remove the mould and clay or dirt attached to them. The rhizomes are socked in water overnight and the next morning they are scraped with a knife to remove the outer cork and little of parenchyma. They are washed again and then dried under sun for a week. The rhizomes are turned by the sides at regular intervals to facilitate proper drying. This is the„ unbleached Jamaica? or the uncoated ginger. The coated or the unpeeled variety is prepared by dropping the rhizome for few minutes in boiling water, and then skin is removed such that the layer on the flat surface is removed but not in the grooves between the branches. The „bleached? or „limed? is prepared by treating it with sulphuric acid or chlorine or dusting it with calcium sulphate or calcium carbonate.

Characterstics

The rhizomes are 5 to 15 cm long, 3 to 6 cm wide, and about 1.5 cm thick. The Jamaica ginger occurs as branches. It has a sympodial branching and the outer surface has buff yellow colour with longitudinally striated fibres. Small circular depressions at the portion of the buds are seen and fractured surface shows narrow bark, a well-developed endodermis, and a wide stele, with scattered small yellowish points of secretion cells and grayish points of fibrovascular bundles. The ginger has agreeable and aromatic odour and pungent and agreeable taste.

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Microscopy

The cork is the outermost layer with irregular parenchymatous cells and dark brown colour. The inner cork is few layered, colourless parenchymatous cells arranged in radial rows. Cork is absent in Jamaica ginger. Phellogen is indistinct and the cortex consists of thin-walled rounded parenchyma with intercellular spaces consisting of abundant starch grains. The starch grains are simple, ovate, or sac shaped. Numerous yellowish brown oleoresin are also present along with the collateral fibro vascular bundles. The endodermis is distinct without starch and consists of single layer of tangentially elongated cells containing suberin. Just below the endodermis it has the ground tissue, a ring of narrow zone of has vascular bundle which is not covered with sclerenchymatous fibres. The ground tissues contain the large parenchymatous cells rich in starch, oleoresin, fibrovascular bundles. The phloem well-developed sieve elements, and the xylem consist of vessels, tracheids either annual or spiral, or reticular in nature without lignin. The fibres are unlignified, pitted, and separate.

1. The ginger rhizome is an aromatic condiment that is available as fresh ginger, preserved ginger, ginger powder, ginger   oil, dry ginger, ginger oleoresin and ginger paste.
2. Medicinal Uses: Ginger rhizome is a rich source of zingiberene, α-curcumene, gingerols, and shogaols. These phytochemical components give it antioxidant, antiinflammatory, Antitussive ,antimicrobial and antilipidemic propertie.

Chemical Constituents

Ginger contains 1 to 2% volatile oil, 5 to 8% pungent resinous mass and starch. The volatile oil is responsible for the aromatic odour and the pungency of the drug is due to the yellowish oily body called gingerol which is odourless. Volatile oil is composed of sesquiterpene hydrocarbon like α- zingiberol; α-sesquiterpene alcohol α-bisabolene, α-farnesene, αsesquiphellandrene. Less pungent components like gingerone and shogaol are also present. Shogal is formed by the dehydration of gingerol and is not present in fresh rhizome.

Synonym : Sacred basil, Holy basil.

species: Ocimum

Family : Labiatae

Kingdom : Plantae

Order : Holy basil

Genus : Basil

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Biological Source:

Tulsi consists of fresh and dried leaves of Ocimum sanctum Linn., belonging to family Labiatae.

Geographical Sources:

It is a herbaceous, much branched annual plant found throughout India, it is considered as sacred by Hindus. The plant is commonly cultivated in garden and also grown near temples. It is propagated by seeds. Tulsi, nowadays, is cultivated commercially for its volatile oil.

Microscopy:

Tulsi leaf is dorsiventral. Stomata are of diacytic type, par-ticularly abundant on lower surface. Epidermal cells are wavy walled with thin cuticle. A single layer of elongated palisade cells is present below upper epidermis. Mesophyll consists of four to six layers of spongy parenchymatous cells with intercellular spaces and oil glands. Leaf bears both covering and glandular trichomes; covering trichomes, uniseriate, multicellular and often very long (100– 400 μ). Glandular trichomes are sessile with radiate head composed of eight cells with common cuticle forming a bladder, typical labiate type trichomes. A few glandular trichomes with unicellular stalk and a spherical unicellular head also occur. The midrib region shows collenchymatous cells below both upper and lower epidermis. Xylem bundles are arranged in an arc. The phloem is arranged on the dorsal side of xylem.

It is much branched small herb and 30 to 75 cm in height. All parts of tulsi are used in medicine, especially fresh and dried leaves. Leaves are oblong, acute with entire or serrate margin, pubescent on both sides and minutely gland-dotted, The leaves are green in colour with aromatic flavour and slightly pungent taste. Flowers are purplish in colour in the form of racemes. Nutlets are subglobose, slightly compressed, pale brown or red in colour. Seeds are reddish-black and sub globose.

Chemical Constiteuents:

Tulsi leaves contain bright, yellow coloured and pleas-ant volatile oil (0.1 to 0.9%). The oil content of the drug varies depending upon the type, the place of cultivation and season of its collection. The oil is collected by steam distillation method from the leaves and flowering tops. It contains approximately 70% eugenol, carvacrol (3%), and eugenol-methyl-ether (20%). It also contains caryophyl-lin. Seeds contain fixed oil with good drying properties. The plant is also reported to contain alkaloids, glycosides, saponin, tannins, an appreciable amount of vitamin C and traces of maleic, citric, and tartaric acid.

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Uses Of Tulsi:

1. 1. 1. 1. Natural Immunity Booster
         2. Reduces Fever (antipyretic) & Pain(analgesic)
         3. Reduces Cold, Cough & Other Respiratory Disorders
         4. Reduces Stress & Blood Pressure
         5. good for diabetes patient

Cinnamon

Cinnamomum is a middle sized evergreen tree, about 10-15 m tall, innate to Southern India and Sri Lanka, but also is found in central to Burma, southern mainland China, Cambodia, Malaysia, Taiwan and Indonesia. In brief, the tree is dispensed in regions between 500 and 1500 m in height. Cinnamon, a plant of the laurel species Lauraceae, as a spice in numerous cultures for centuries, has been consumed in China for thousands of years against many diseases, for instance the “thirsty disease,” which was an old expression for diabetes in China before the expression diabetes mellitus was created in modern medicine.

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Fig. 5 Cinnamon

Synonym: cinnamon bark, kalmi-dalchini.

Species: loureiroi

Order: laurales

Genus: Cinnamomum

Medicinal use:

Mostly use for treatment ofcough, carminative, stomachic, mild astringent, flavouring agent, aromatic agent, use as aspice and condiment

Chemical constituent:

The constituents of procyanidins contain both procyanidin A-type and B-type bonds. These procyanidins are taken out from cinnamon and berries. They also own antioxidant activities. In the same way, the most important ingredients of cinnamon is trans-cinnamaldehyde or cinnamaldehyde which exists in the essential oil, therefore donating to the fragrance and to the diverse biological activities perceived with cinnamon. Essential oil from cinnamon leaves includes a high level of cinnamon. Subsequently, C. osmophloeum is also used as a replacement spice for C. cassia. One of the main constituents of essential oil obtained from C. zeylanicum termed (E)-cinnamaldehyde has an antityrosinase activity, whereas cinnamaldehyde is the main compound accountable for this activity. Utilization of cinnamon (short term) is related with a notable decrease in systolic Blood Pressure (BP) and diastolic BP.

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MATERIALS AND METHODS:

Table 6.1: List of Materials

Glassware’s and instruments:

Glassware: –

Beaker, Measuring cylinder, Stirrer, morter pestle, Seive no.20

Instrument: –

Hot air oven, Punching machine, etc.

Drugs and chemicals:

1. Lactose
2. Magnesium stearate
3. Methyl cellulose
4. Sucrose
5. Gum acacia
6. Talc

METHODOLOGY:

There are thre methods by which tablets are manufactured.

1. Wet granulation
2. Dry granulation
3. Direct compression

Wet granulation method:

1. 1. 1. All herbal ingredient were collected and dried.
      2. Herbal ingredients grinded using domestic mixer.
      3. The required quantity of ingredients were weighed and taken in mortar. Methyl cellulose, magnesium stearate, sucrose is added into ingredients.
      4. All ingredients are properly mixed in a mortar.
      5. Gum acacia, sucrose and Lactose are mixed with water and solution is formed ,the solution is boiled for five minutes until the gum acacia not dissolved
      6. Cool the solution
      7. Take all mixed ingredients into petri dish and add the gum acacia solution into it and form a slug
      8. Transfer the slug from sieve no.20 granules are formed
      9. Put the granules into hot air oven for 30 minutes at 60°C

10. Take the granules and add into mortar and grind the granules into mortar until uniform powder not formed.

11. Punch the tablet using punching machine.

Evaluation Parameter Pre-Compression Test

1. Angle of repose:

Determined by using the funnel method. Accurately weighed granules were taken in a funnel and the height of the funnel was adjusted in such a way that the tip of the funnel just touches the apex of the heap. The granules were allowed to flow through the funnel freely onto the surface. The diameter of the powder cone was measured and angle of repose was calculated from the following formula.

tan ? = h/r Where, θ = angle of repose, h = height of powder cone formed, r = radius of powder cone formed Loose

2. Bulk density (LBD):

Determined by pouring a weighed quantity of granules into a graduated cylinder and measuring the volume and weight. LBD = Weight of the powder / volume of the packing

3. Tapped bulk density (TBD)

Determined by placing a graduated cylinder, containing a known mass of granules. The cylinder was allowed to fall under its own weight onto a hard surface from the height of Gajanan Maharaj College of Pharmcy 32 10 cm at two second intervals. The tapping was continued until no further change in volume was noted. TBD = Weight of the powder / volume of the tapped packing.

Post-compression Test

1. Weight Variation:

10 tablets were selected randomly and weight individually. The average of tablets is calculated using formula and the Standard deviation is calculated by using following formula

Standard Deviation (S.D.) = √ Deviation² (D²)/ No. of tablets (N)

2. Hardness test:

This test is done using the Monsanto and Pfizer apparatus. In this the tablet is kept in its place in the apparatus and the pressure is applied to it. The pressure is noted down which have been recorded by the pressure gauge and average hardness is calculated.

3. Friability Test:

This test is carried out by using Friability apparatus. The weighted tablets are placed in the apparatus and it is rotated at 25 rpm for 5 minutes. After sometimes tablets are removed out from apparatus and again they are weight. The friability is calculated by using following formula:

Friability = Initial weight (Wi) – Final weight (Wf) /Initial weight (Wi)*100

4. Acceptability test:

In this test the acceptability of the tablets is checked, whether the tablets are suitable to eat or not. The sweetness & odour of tablets are tested by 5 volunteers and the acceptance is noted down in the table with the remarks given by each volunteer regarding the tablets.

5. Disintegration test:

6 tablets are taken for the evaluation of the disintegration time. The tablets are placed in the disintegration apparatus and the time is observed till the tablet gets totally disintegrated. The temperature of the apparatus is maintained at 37º C.

6. Dissolution test:

6 tablets are taken for evaluation of the dissolution rate. The tablet are placed in the dissolution apparatus and the time is observed till the tablet gets totally dissolve. The temperature of the apparatus is maintained at 37º C.

RESULT AND DISCUSSION: