Medicinal plants, since times immemorial, have been used in virtually all cultures as a source of medicine. The widespread use of herbal remedies and healthcare preparations, as those described in ancient texts such as the Vedas and the Bible, and obtained from commonly used traditional herbs and medicinal plants, has been traced to the occurrence of natural products with medicinal properties. The use of traditional medicine and medicinal plants in most developing countries, as a normative basis for the maintenance of good health, has also been widely observed. Furthermore, an increasing reliance on the use of medicinal plants in industrialized societies has been traced to the extraction and development of several drugs and chemotherapeutics from these plants as well as from traditionally used rural herbal remedies. The World Health Organization has estimated that 80% of the world’s population use botanical medicine for their primary health care needs. ⁽¹⁾ Medicinal plants are an important therapeutic agent for eliminating health- related risks of human being and its witness has been given by their presence in Rigveda and Ayurveda. The rate of prevalence of diseases, as well as discomfort, has increased in the recent era. This situation has to lead the researchers to explore different medicinal as well as herbal plants to eliminate this problem. As per the reports presented by WHO, 80% of the population all over the world implement remedial herbs to heal diseases as the most impor-tant therapy at a basic stage. The use of these medicinal plants having disease curing activity has been widely proposed in most developing countries, on a normal basis these plant sources act as a remedy for health benefits. ⁽²⁾ Medicinal plants, since times immemorial, have been used in virtually all cultures as a source of medicine. The widespread use of herbal remedies and healthcare preparations, as those described in ancient texts such as the Vedas and the Bible, and obtained from commonly used traditional herbs and medicinal plants, has been traced to the occurrence of natural products with medicinal properties (Hoareau & DaSilva, 1999). The use of traditional medicine and medicinal plants in most developing countries, as a normative basis for the maintenance of good health, has also been widely observed (UNESCO, 1996). Furthermore, an increasing reliance on the use of medicinal plants in industrialized societies has been traced to the extraction and development of several drugs and chemotherapeutics from these plants as well as from traditionally used rural herbal remedies. The World Health Organization has estimated that 80% of the world’s population use botanical medicine for their primary health care needs.⁽³⁾ Solid  medicaments  may  be  administered orally as powders, pills, cachets, capsules or  tablets. These  dosage  forms  contain  a quantity of drug which is given as a single Unit  and  they  are known  collectively  as solid unit dosage forms, even in the case of Sustained  action  preparations  which, technically,  contain  the  equivalent  of several  Normal  doses  of  drug  The stringent  formulation  requirements  of modern  Medicaments,  the  many advantages  of  tablet  and  capsule medication,  coupled  With  expanding health services  and  the commitment  need for  large scale  Economic  manufacture, have  led  to  a  steady  decline  in  the prescribing of  powders And  pills  .Tablets and capsules, on the other hand, currently account for  well  over  Two  third  of  the total  number  and  cost  of  medicines produced  all  over  the  world.  Tablets are solid  dosage  form  which  is  the conventional  as  well  as  have  many reviewed. advantages over  other  dosage  forms. Tablets are the most popular dosage form: about 70% of  the  total  medicines  are dispensed  in  the  form  of  tablet.  Tablets had different  shapes,  sizes,  as  well  as weight depending on medicinal substances and the  intended mode  of administration.   In this paper the some  advantages as well as some disadvantages of tablets, the basic ingredients  that  are  commonly  found  in tablets, methods of  tablet  preparation and the various types of the  tablets are briefly reviewed.⁽³⁾

Definition of Tablet

According to  the  Indian  Pharmacopoeia Pharmaceutical  tablets  are  solid,  flat  or biconvex  dishes,  unit  dosage  form, prepared  by  compressing  a  drugs  or  a mixture of drugs, with or without diluents. Tablet  is  defined  as  a  compressed  solid dosage form containing medicaments with or without  excipients. They vary in  shape and  differ  greatly  in  size  and  weight, depending  on  amount  of  medicinal substances  and  the  intended  mode  of administration.^(4,5)

Tablet is defined as a compressed solid dosage form containing medicaments with or without Excipients. 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.^(4,5)

Properties⁽⁵⁾

• Should  be  elegant  product  having  its own  identity  while  being  free  of defects  such     as  chips,  cracks, discoloration and contamination.

• Should have strength to  withstand  the rigors  of  shocks  encountered  in  its production,     packaging,  shipping  and dispensing.
• Should  have  the  physical  stability  to maintain  its  physical  attributes  over time.
• Must  be  able  to  release  the medicament agent(s)  in  the body in  a predictable and reproducible manner.
• Must have a suitable chemical stability over time so as not to allow alteration of the medicinal agent(s).

Advantages (6)

• They are easy to carry, easy to swallow and they are attractive in appearance.
• Unpleasant taste can be masked by sugar coating and they do not require any measurement of dose.
• Some of the tablets are divided into halves and quarters by drawing lines during manufacturing to facilitate breakage whenever a fractional dose is required.
• An accurate amount of medicament, even if very small, can be incorporated.
• Tablets provide best combined properties of chemical, mechanical and microbiological stability of all the oral dosage forms.
• Since they are generally produced on a large scale, therefore, their cost of production is relatively low, hence economical.
• They are in general the easiest and cheapest to package and ship among all oral dosage forms. Some specialized tablets may be prepared for modified release profile of the drug.
• Product identification is potentially the simplest and cheapest requiring no additional processing steps when employing an embossed or monogrammed punch face.

Disadvantages (6)

• Difficult to swallow in case of children and unconscious patients.
• 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 odor or drugs that are sensitive to oxygen may require encapsulation or coating.
• In such cases, capsule may offer the best and lowest cost. Some drugs resist compression into dense compacts, owing to amorphous nature, low density character.

Plant profile

Ficus racemosa Linn is a beautiful cluster-fig tree with a curved trunk and a spreading crown. It   is not a banyan tree; it does not have aerial roots. The red, stubbly figs in little bunches that grow immediately out of the tree's trunk are the most eye-catching feature of this tree. Those hunting for Ficus racemosa blooms should know that the fig is a component of a tree with hundreds of blossoms. The blossoms are pollinated by extremely little wasps that go through the aperture, looking for a suitable spot to reproduce. Without these pollinators, fig-trees never reproduce by seed.

In response, the blooms provide a safe home and nutrition for the wasps' offspring. Ficus racemosa is a ubiquitous tree in villages, cities, and towns. (7)

       
           
       
Fig 1. Ficus racemosa Linn.(7)

Taxonomic classification

The taxonomical classification has been represented in Fig.2

Vernacular names:

Hindi : Gular, Umar

Beng : Dumar, Jagya domar

Mar : Umbar

Guj : Umar, Gular

Tel :Atti bodda, paidi, udumbara

Tamil, Kan, Mal : Athi

Oriya : Dimpri⁽⁸⁾

Sans : Udumbarah, Sadaphakh

Assam : Janyedumuru, Yagyadimru

English : Cluster Fig, Country fig⁽⁹⁾

Climate and soil

It is naturally coming up in waste lands and forests. This requires well drained, medium to heavy soil for its successful cultivation. It is also found to be tolerate to lime sulphates and chlorides and can be thus used for planning in industrially polluted sites. However, it is not resistant to carbonates of sodium, potassium. It comes up in all kinds of soil except in water logged and clay types.⁽⁹⁾

Habits and features

Moderate to large sized spreading laticiferous, deciduous tree without much prominent aerial roots. It is an evergreen tree, 15-18 m high, young shoots glabrous.⁽⁹⁾

Leaves

Dark green leaves 7.5-15×3.2-6.3 cm, ovate – oblong (or) elliptic, lanceolate, tapering to a blunt point at the apex, with entire margins glabrous on both surfaces, base acute and rounded 3 nerved, lateral main nerves 4-6 pairs, petioles 1.3-3.8 cm long, glabrous stipules 2 cm long, ovate – lanceolate, scarious, pubescent. Leaves shed by December, replenished by January and April when the tree becomes bare for a short period.⁽¹⁰⁾

Inflorescence

Hypanthodium- Three kinds of flowers are borne, sterile, male and female flowers together in one receptacle of hypanthodium. The male flowers forming a zone near the mouth, the fertile female flowers forming a layer in the walls of the receptacle and the gall flowers an internal layer. Receptacle short pedunculate on short leafless warted branches which issue from the stem and later branches much contracted at the base when young.⁽¹¹⁾

Flowers

Basal bracts 3, ovate-triangular, Male flower sessile, sepals 3-4 membranous, inflated enveloping the 2 elongate ovate anthers, filaments connate. Fertile female flowers sub-sessile, perianth gamophyllous with 4 or 5 long lanceolate teeth enveloping the small minutely tuberculate achene, style sub-terminal, stigma clavate. Gall flowers pedicellate, perianth gamophyllous, irregularly toothed covering only the base of the rough ovoid style, lateral elongate, stigma clavate. have a pleasant odour, resembling that of cider apples. The syconns develops from a hollow, pear-shaped fleshy receptacle which encloses a number of minute male and female flowers. The receptacle grows and becomes fleshy encloses a number of fruits or achene which develop from the female flowers lying within the receptacle.⁽¹²⁾

Bark

The bark is astringent, rusty brown with a firmly smooth and soft surface, thickness from 0.5-2 cm according to the age of the trunk or bark surface with minute separating flakes of whitish tissue, texture homogenous leathery.⁽¹²⁾

Parts used - Root, bark, leaves, fruits, milky juice.⁽¹²⁾

Action

Fruits – Laxative, Improves blood, cooling⁽¹²⁾

Bark leaves and unripe fruits – Astringent, Carminative, Stomachic, Vermicide.⁽¹³⁾

Phytochemicals Aspects

The active phytochemical constituents of Ficus racemosa have been described in Table  The structures with their stereochemistry have been noted in Fig.

       
           
       
    
       
           
       
Fig: Chemical structure of the active constituents of Ficus. racemosa.(32)

SEED - Powder of the seed mixed with honey is regarded a specific in diabetes, reducing sugar in the urine, thirst and polyuria of diabetes.⁽¹³⁾

LEAVES - Young leaves crushed or reduced to powder or ripe figs mixed with honey or sugar are administered in bilious affections. Decoction prepared with a handful of leaves boiled in four pints of water is given with benefit every morning as a douche in dysmenorrhea.⁽¹³⁾

MILKY JUICE - Milky juice is administered in piles and diarrhoea.  Fruit is edible, it is given on aphthous complaints, menorrhagia, haemoptysis with sugar and honey. Fruit when boiled in milk, it is a good remedy for visceral obstructions. In the diarrhoea of the pregnant women, the fruit with honey is given. Fruit and sap extracted from the trunk of the tree are efficacious in diabetes. Fruits are suppressor of pitta and effective in removing srama and sopha. The powder from the roasted fruits form a valuable breakfast food, almost similar to imported grape nuts. Fruits may be dehydrated ground in to flour and taken with milk and sugar or used for preparing cold jelly. Fresh juice of ripe fruit is given as an adjunct or vehicle to a metallic medicine for diabetes and other urinary complaints. Dried fruit one tola with sugar and honey is given in cases of menorrhagia and haemoptysis.⁽¹³⁾

Materials and Methods

Collection and Authentication of plants

Bark of Ficus racemosa were collected from Tirupati Nagar, Kathora road, Amravati(Maharashtra).The plant was identified and authenticated by Dr. Parul Nandgaonkar of department of Dravyaguna ,P.R.Pote Patil College Of Medical Sciences Ayurved, Amravati, and a voucher sample (code:DGH/24005 dated 05/03/2024) was deposited at the Herbarium of this department. The bark was dried in the sun exposure. Dried bark were powdered in grinder and powder was kept in an airtight container for further study. According to the literarure survey the methanolic extract of bark of Ficus racemosa Linn. Shows significant anti-pyretic activity.

Various excipients are required for the herbal tablet formulation including binders, fillers,      dinintegrants, lubricants etc.

Extraction of Plant Material

The dried bark of plant Ficus racemosa Linn were allowed to air dry in a shade under normal environmental conditions for about one week, after that broken in to small pieces with the help of cutter and grinded in a grinder to coarse powder. Coarsely grinded plant parts were extracted in soxhlet apparatus successively with solvents ethanol. Table  shows percentage yield of successive extraction.

       
           
       
Fig 3. Extraction of Ficus racemosa Linn of bark extract

Preformulation Study⁽¹⁴⁾

Taste, sight, smell, touch, and other senses are among the qualities of food, medications, and other substances that are referred to as organoleptic characteristics. These attributes are essential for evaluating the therapeutic efficacy, acceptability, and quality of herbal products.

The Organoleptic properties are crucial for customer acceptance and safety in addition to guaranteeing the effectiveness and purity of herbal products.

Bulk density and tap density

Important factors in the formulation and quality assurance of herbal tablets include bulk and tapped density. The mass of a powder divided by its volume when loosely packed is known as bulk density, and it represents the initial state of the powder prior to any compaction or compression. Conversely, tapered density is the mass of the powder divided by volume following normal tapping or vibration treatment, which compacts the powder and lowers its volume. comprehension the powder's flow characteristics and its capacity to form a tablet requires a comprehension of these metrics. Consistent tablet weight and active ingredient distribution depend on adequate flowability and uniform packing, which are often indicated by high bulk and tapped densities. The measured difference between these densities.

Compressibility

Herbal product compressibility is a crucial factor in product development and quality assurance, especially when it comes to tablets or powders. It is essential to the creation of tablets and describes a powder's capacity to reduce in volume when subjected to pressure.

Development of Formulation^(14,15)

All ready standardized methanolic bark extract from Ficus racemosa Linn were used to prepared granules by wet granulation technique as follows:

• Following the addition of lactose to absorb moisture, the precisely weighed extract amounts were put through sieve number 60.
• Add enough isopropyl alcohol to the mixture together with weighed amounts of the excipients (Starch, PVPK-30, Sodium methyl paraben, and Sodium propyl paraben) to create dough mass.
• The wet mass was passed through sieve no.12.
• Granules were dried for 30 minutes at 50–55 °C in an oven.
• Dried granules were passed from sieve no. 20.
• Then granules were mixed with Lubricants (Talc, Magnesium stearate & Sodium  starch glyconate).

• The granules developed in this study were evaluated to ensure, that they meet the specified formulation criteria. (e.g.practicle size, dissolution rate,stability,etc,).
• Based on the results obtained from the tests it is confirmed that the granules prepared  according to the formula 3 (table no.1) comply with the formulation.
• 40 tablets for 250 mg were prepared.

Compression Process:

The formulation consisted of methanolic extract of bark of ficus racemosa Linn. in defined properties. Wet granulation was performed Magnesium stearate was used as a lubricant. Tablets were compressed with a target weight of 250 mg each.

Evaluation of Tablet Formulation⁽¹⁵⁾

Tablets prepared by compression method were evaluated for General Appearance, Weight Variation, Thickness of Tablet, Hardness of Tablet, Friability, Disintegration time, dissolution test as per IP.

1.General Appearance:

Consumer acceptability, lot-to-lot uniformity control, and tablet-to-tablet uniformity are all dependent on a tablet's overall look, identity, and general elegance. Measurements of size, form, color, taste, odor, and other elements are all part of controlling overall appearance.

2.Size & Shape:

Tablets can be made in virtually any shape, although the requirements of patients and tableting machines mean that most are round, oval, or capsule-shaped.Different shapes tablets have a diverse range of sizes but generally size of tablets is in the range of about 1mm to 22 mm. FDA has recommended that size of tablet should not be more than 22 mm.Size of tablet impacts the passage of tablets through pharynx. Large sized tablets get lodged in the esophagus resulting in the dissolution of drug in esophagus which causes injury to esophagus, pain, and ulceration.

3. Organoleptic properties:

The freshly peeled and the dried stem barks were spread on a clean dry plastic sheet and investigated different organoleptic features such as condition, thickness, color, odour, taste and fracture by repeated observations using a magnifying glass (where required) and recorded.

4. Hardness:

A tablet needs to be strong enough to endure mechanical shaking during manufacturing, packing, and delivery, as well as resistant to friability. In general, hardness indicates how strong a tablet can be crushed.

5. Weight Variation test (U.S.P.):

20 tablets should be taken and weighed separately. Compute the mean weight and contrast each tablet's weight with the mean. If no more than two tablets deviate from the % restriction and if no tablet varies by more than twice the percentage limit, the tablet passes the U.S.P. test.

5. Disintegration Test (U.S.P.):

The U.S.P. apparatus for testing disintegration consists of six three-inch glass tubes with 10 mesh screens at the bottom end and an open top. One pill is put in each tube to measure the disintegration time, and the basket rack is set up in a 1-liter beaker of water. either simulated intestinal fluid or simulated gastric fluid at 37 ± 20 C so that the tablet stays 2.5 cm below the liquid's surface throughout its upward movement and does not come any closer to the beaker's bottom during its downward movement. Move the tablet-containing basket up and down at a rate of 28 to 32 cycles per minute over a distance of 5 to 6 cm. It is possible to stop the tablets from floating.

6. Dissolution Test

The United States Pharmacopoeia (USP) dissolving apparatus is essential for guaranteeing the effectiveness, safety, and quality of oral dosage forms. In order to predict the release and bioavailability of active pharmaceutical substances, it stimulates gastrointestinal conditions. This helps with formulation development and ensures uniformity between batches.To ensure that products fulfill strict quality control criteria, regulatory approval requires compliance with USP standards or dissolution testing. Dissolve testing also supports comparative evaluations and stability investigations between name-brand and generic drugs, maintaining patient safety and therapeutic dependability.

RESULTS AND DISCUSSION

       
           
       
Table no. 2: Organoleptic features of Ficus racemosa Linn. Bark

Precompression Parameters:

Around 40 tables were prepared and pharmaceutically evaluated. The results observed are as follows: