INTRODUCTION:
According to the Indian Pharmacopoeia (IP); Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drug or a mixture of drugs, with or without diluents. According to the United States of Pharmacopoeia (USP); Tablet is defined as a compressed solid dosage form containing medicaments with or without excipients.
Advantages of tablet dosage form:1,2,3
· They are unit dosage forms and offer the greatest capabilities of all oral dosage forms for the greatest dose precision and the least content variability.
· Ease of accurate dose.
· Release rate of the drug from tablets can be tailored to meet pharmacological requirements.
· Easiest and cheapest to package and strip.
· Easy to swallow with least tendency for hang‐up.
· Sustained release product is possible by enteric coating.
· Objectionable odour and bitter taste can be masked by coating technique.
· Greatest chemical and microbial stability over all oral dosage forms.
· Product identification is easy and rapid requiring no additional steps when employing an embossed and/or monogrammed punch face.
Disadvantages of tablet dosage form:
· Difficult to swallow in case of children and unconscious patients.
· Some drugs resist compression into dense compacts, owing to their amorphous nature, low density character.
· Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may be difficult to formulate or manufacture as a tablet that will still provide adequate or full drug bioavailability.
· Bitter testing drugs, drugs with an objectionable odour or drugs that are sensitive to oxygen may require encapsulation or coating. In such cases, a capsule may offer the best and lowest cost.
Importance of Herbal Medicine:4
Herbal Medicine is the oldest form of health care known to manhood. Herbs had been used by all cultures throughout history. It was an integral part of the development of modern civilization. Rude man observed and appreciated the great diversity of plants available to him. The plants provided food, clothing, shelter and medicine. Much of the medicinal use of plants seems to have been developed through observations of wild animals and by trial and error. As time went on, each tribe added the medicinal power of herbs in their area to its knowledge base. They systematically collected information on herbs and developed well-defined herbal pharmacopoeias. Certainly, well into the 20th century much of the pharmacopoeia of scientific medicine was derived from the herbal tradition of natural people. Many drugs commonly used today are of herbal origin. Certainly, about 25 percent of the prescription drugs dispensed in the United States contain at least one active ingredient derived from plant material. Some are made from plant extracts; others are synthesized to copycat a natural plant compound. Herbal medicinal products are defined as any medicinal product, exclusively containing one or more active substances. WHO report 80% of the world population trusts on the drug from natural origin.
A number of traditional herbal medical applies have been accepted for the diagnosis, prevention and treatment of various diseases. Many such practices were experimentally proved showing the scientific vision behind their traditional adoption. This attempts to prove scientific vision behind the traditional adaption. Less toxicity, better therapeutic effect, good patient compliance and cost effectiveness are the Reasons for choosing drug from natural origin.
A large number of medicinal plants are used in the treatment of Inflammation as well as pain. Inflammation is generally defined as a response to stimulation by invading pathogens or endogenous signals such as damaged cells that results in tissue repair or sometimes pathology, when the response goes unchecked. However, understanding of the mechanisms, context and role of inflammation during physiological immune responses and pathology is constantly evolving.
We found practically and theoretically treatment of inflammation in Ayurveda by increase the immunity. Keeping in view of the importance of the disease and also considering the fact that green medicine is safe. So, we believed to select an herbal origin drug for this project. Multi-herbal drugs like ginger, turmeric and moringa are good anti-inflammatory agents. so, it was very interesting to select this plant which can help in the treatment of inflammation along with its major complication of the disease. The main objective of this present study was to investigate and formulate well tolerated, ecofriendly and cost-effective herbal tablet containing anti-inflammatory drugs. During the course of present investigation its pharmacognostical studies, and then formulation of the crude powders as a tablet dosage form, pre-formulation studies and in vitro evaluation of the tablets like disintegration test as per I.P.
Pharmacognosy of crude drugs involve in formulation:
1. Ginger:5
Synonyms: Zingiber, Zingiberis, Sunthi.
Biological Source: Ginger consists of whole or cut, dried scrapped or unscrapped rhizomes of Zingiber officinale Roscoe, family Zingiberaceae. It contains not less than 0.8 per cent of total gingerols on dried basis.
Chemical Constituents:
Ginger consists of volatile oil (1-4 percent), starch (40-60 percent), fat (10 percent, fibe percenti, inorganic material (6 percent), residual moisture (10 percent) and acrid resinous matter 158 percent). Ginger oil is constituted of monoterpene hydrocarbons, sesquiterpene hydrocarbons, oxygenated mono and sesquiterpenes, and phenyl propanoids.
Sesquiterpene hydrocarbon content of all types of ginger oil from different countries is found to be same and includes a-zingiberene, B-bisabolene, a-farnesene, B-sesquiphellandrene and curcumene.
Aroma and flavour are the main characters of ginger. Aroma is due to fragrant principles of volatile oil while the flavour, pungency and pharmacological action is exerted by phenolic ketones of oleo-resin. Various components of volatile oil like isometric terpenic aldehydes like geranial and citral, which cause the delicate and lemony aroma. Few sesquiterpene oil hydrocarbons are believed to exert spicy note.
Phenolic ketones of oleo resin include gingerols like shogaols, zingerone, paradols, gingediols, hexahydrocurcumin and also o-methyl ethers of these compounds.
Uses: Ginger is used as a stomachic, an anti-inflammatory, an aromatic, a carminative, stimulant and flavouring agent. Ginger oil is used in mouth washes, ginger beverages and liquors.
Ginger powder has been reported to be effective in motion sickness. It has been suggested that adsorbent, aromatic and carminative properties of ginger on G. I. tract cause adsorption of toxins and acid enhanced gastric motility. These may have probably blocking effects of G. I. reactions and nausea.
2. Haridra:5
Synonyms: Indian saffron, Curcuma, Turmeric, Haldi
Biological Source: Turmeric consists of dried, as well as, fresh rhizomes of the plant known as Curcuma longa Linn. (C. domestica), belonging to family Zingiberaceae. It contains not less than 1.5 percent of curcumin.
Chemical constituents:
Turmeric contains about 5 percent of volatile oil, resin, abundant zingiberaceous starch grains and yellow colouring substances known as curcuminoids. The chief component of curcuminoids known as curcumin (50-60 per cent). Chemically, Curcuma species contain volatile oil, starch and curcumin. Curcumin and other related curcuminoids such as Demethoxy curcumin and Bis Demethoxy curcumin are reported to be responsible for the yellow colour in some species. Volatile oil content ranges from 1-6.5 percent and is composed of mono and sesquiterpene such as alpha and ẞ pinene, alpha-phellandrene, camphor, camphene, DL-ar-termerone zingiberene and alpha, ẞ curcumenes Species like C. angustifolia and C. caulina have high starch content and are used as a substitute for arrow root.
Uses: Turmeric is used as a condiment or spice, and colouring agent, especially for ointments and creams. Chemically, it is used for the detection of boric acid. It is antiseptic and anti-inflammatory. Curcumin is also powerful antioxidant.
3. Moringa oleifera:6
Synonyms: Horse radish tree and drum stick tree.
Biological source: It consist of whole plant munga belonging to family moringaceae
Chemical constituents:7
Munga plants provide large and rare combination of zeatin, quercetin, beta – sitosterol, kaemopferol, and caffeoylguinic acid. Vital minerals present in the Moringa oleifera include iron, potassium, calcium, copper, zinc, magnesium, manganese etc. Other most important and valuable species of plant Moringa are M. oleifera, M. arborea, M. drouhardii, M. ovalifolia, M. longituba, M. rivae, M. borziana, M. corcanensis, M. hildebrandtii, M. ruspoliana, M. stenopetala, M. peregrine, M. pygmaea. different parts of the plant such as bark, leaves, seeds, flowers, roots, and immature pods, contains large number of important phytoconstituents such as terpenoids, alkaloids, tannins, steroidal aglycones and reducing sugars. Plant leaves contain essential amino acids to build strong healthy bodies.
Uses: Moringa oleifera leaves have been used in traditional medicine system for centuries, in the ayurvedic system of medicine associated with the cure or prevention of the diseases because of its water compelling, water purification capacity and high nutritional importance. Plant leaves are tiny and difficult to harvest and use a rich nutritional profile of leaves which contains vitamins, minerals and essential amino acids. One hundred grams of dry Moringa oleifera leaf contains 9 times the vitamin A of carrots, 15 times the potassium of bananas, 17 times the calcium of milk, 12 times the vitamin C of oranges and 25 times the iron of spinach. Antioxidants galore and plant leaves of munga contains rich source of antioxidants, including beta carotene, vitamin C, quercetin and chlorogenic acid. Chlorogenic acid has been found to lower blood sugar levels7. The leaves and seeds of Moringa oleifera Lam. may protect against some effects of the arsenic toxicity which is especially important light of news. Contamination of ground water by arsenic has also become a cause of global public health concern. Moringa oleifera seeds have even been found to work better for water purification function8.
Anti-inflammatory activity:9
Methanolic and aqueous extract of root and bark, methanolic extract of leaves and flowers and ethanolic extract of seeds of Moringa oleifera possess anti-inflammatory activity. In-vitro anti-inflammatory activity from the hot water infusions of flowers, leaves, roots, seeds and stalks or bark of Moringa oleifera using carrageenan-induced and the extract was pharmacologically evaluated.
MATERIAL AND METHODS:
Ginger (200g), Honey (100ml), Akhi Haldi (200gm) and drum stick (250gm) were obtained from Jamner at the local market. Additional additives are obtained from Department of Pharmaceutics and Pharmacognosy of SSJIPER Jamner.
Ginger and Raw haldi and drum stick was dried and ground to the desired particle size using a Cutter mill i.e. Jyoti Mixer and mortar pestle. The desire particle size obtains by mechanical sieving process.
Formulation table:
Table No. 1: Formula for each Herbal tablet
|
Sr. No. |
Name of ingredients |
Use of ingredients |
Amount of ingredients (mg) |
|
1. |
Ginger powder |
Anti-inflammatory agent |
300mg |
|
2. |
Turmeric powder |
Anti-inflammatory agent |
300mg |
|
3. |
Moringa powder |
Anti-inflammatory agent |
300mg |
|
4. |
Ground white paper |
Flavouring agent |
1.5mg |
|
5. |
Starch |
Disintegrants |
1.5mg |
|
6. |
Honey |
Flavouring agent/ binder |
q.s |
|
7. |
lactose |
Diluent |
q.s. |
Procedure:
· In this formulation, the dried powders of ginger, turmeric and moringa was used to form a tablet dosage form.
· The formulation was done by following the wet granulation process and further compression by using hand operated tablet punching machine.
· Weigh all ingredients accurately by using weighing balance.
· Mix all dry powders and triturate by using mortar and pestle.
· The prepared mixture mixed with honey to form a damp mass.
· In damp mass diluent is added.
· The mass was transfer through sieve no. 22.
· Prepared granules are dried at room temperature.
· The well dried granules are ready for compression to form tablet.
Figure No. 1: Formulated Poly herbal tablet
5. Evaluation of tablet:10
5.1. Pre-formulation study:
5.1.1. Bulk density:
Bulk density was carried out in 100ml dried measuring cylinder. Pouring of dried granules in measuring cylinder and calculated by using the following formula;
Bulk density = Mass of the granules/Bulk volume of the granules
5.1.2. Tapped density:
Tapped density was carried out by pouring of dried granules in 100ml measuring cylinder.100 tapping was done, note down the volume and calculate by using the following formula;
Tapped density = Granules weight/Volume of tapped granules
5.1.3. Hausner’s ratio:
Hausner’s ratio is the ratio of the tapped density of granules to the bulk density of granules. Calculated by using the following formula.
Table 2 shows the flow property of granules.
Hausner’s ratio= Tapped density/Bulk density
5.1.4. Carr’s index or compressibility index is determined by the following formula. Table No.2 shows the flow property of granules.
(Tapped density – Bulk density)
Carr’s index = ------------------------------------------
Tapped density
5.1.5. Angle of repose:
Angle of repose was determined by using the funnel method.
Following formula was used to calculate the angle of repose. Table No.2 shows the flow property of granules.
ϴ = Tan-1[h/r]
Where h = height of granule cone formed.
r = radius of the granule cone formed.
5.2. Physical evaluation of tablets:11,12
The tablets were subjected to the following evaluation tests.
5.2.1. General appearance:
The general appearance and colour of tablets were found by visual determination. Result is show in table No.3.
5.2.2. Weight variation test:
The weight variation test was performed by following procedure.
Weigh 20 tablets individually and consider as X1, X2,X3,…. .X20. Determine the average weight of 20 tablets X= (X1+X2+X3+….+X20)/20. The individual weight was compared with the upper limit and lower limit. Not more than two of the tablets differs from the average weight by more than the % error listed, and no tablets differ by more than double that percentage. Result is show in table No.3.
5.2.3. Hardness and thickness test:
the hardness and thickness of 20 tablets were determined. Hardness test was determined by Monsanto hardness tester and the thickness of tablets was determined by Vernier Callipers. Results is show in table No. 3.
5.2.4. Friability test:
Friability of a tablets can determine in a laboratory by Roche friabilator. The friabilator consists of plastic chamber that rotates at 25rpm, dropping the tablets through a distance of six inches in the friabilator, which is then operated for 100 revolutions. The tablets are reweighed. Compress tablets loss less than 0.5% to 1.0% of the tablet weight are considered acceptable. Result is shown in table No.3.
5.2.5. Disintegration time This test was a time required for the tablet to separate into particles, the disintegration test measure only of the time required under a given set of a conditions for a group of tablets to disintegrate into particles. This test was performed to identify the disintegration of tablet in a specific time period. Result is shown in table No.3.
RESULTS:
The formulation was prepared by wet granulation method were tested for pre-formulation studies for the effective evaluation of tablets. All the evaluated pre-formulation parameters are shown in table 4. Based on the pre-formulation study the flow property of granules was good. The physical parameters of compressed tablets were shown in table 5. The compressed tablets colour was reddish brown The weight variation test, hardness, thickness, friability and disintegration time were shown in table 5.
Table No. 2: Pre-formulation result of herbal tablet
|
Sr. No. |
Evaluation parameter |
Result |
Conclusion |
|
1 |
Bulk density |
0.29g/m3 |
- |
|
2 |
Tap density |
0.33g/m3 |
- |
|
3 |
Carr’s Index |
14.31% |
Good |
|
4 |
Hausner’s ratio |
1.24 |
Fair |
|
5 |
Angle of repose |
31.22 |
Good |
Table No. 3: Physical evaluation result of herbal tablet
|
Sr. No. |
Evaluation parameter |
Result |
|
1 |
General appearance |
Reddish brown |
|
2 |
Weight variation (mg) |
986±5% |
|
3 |
Hardness (kg/cm2) |
3.13±0.11 |
|
4 |
Thickness (mm) |
4.37±0.005 |
|
5 |
Friability |
0.81% |
|
6 |
Disintegration (min) |
29 min |
CONCLUSION AND DISCUSSION:
Herbal products may contain a single herb or combinations of several different herbs believed to have complementary and/ or synergistic effects. Some herbal products, including many traditional medicine formulations, also include animal products and minerals. Herbal products are sold as either raw plants or extracts of portions of the plant. All the above formulated crude drugs are traditional medicinal plant which having various medicinal activities but present research was focused on anti-inflammatory activity. The powders of all 3 formulated crude drugs were used to formulate tablets. Wet granulation was done by using different excipients and making the tablets. Pre-formulation study was carried out and gives good flow properties of prepared granules. The compression of prepared tablets, were evaluated and gives satisfactory results. The tablet was more disintegration time as coated tablet. Based on the results it is concluded that the formulation and evaluation are good.
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Received on 29.07.2024 Revised on 07.09.2024 Accepted on 19.10.2024 Published on 20.12.2024 Available online from November 25, 2024 Res. J. Pharmacognosy and Phytochem. 2024; 16(4):225-229. DOI: 10.52711/0975-4385.2024.00042 ©A&V Publications All right reserved
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