1221am - 22.EPRA JOURNALS-6734
1221am - 22.EPRA JOURNALS-6734
1221am - 22.EPRA JOURNALS-6734
Shikha Thakur1*
1
Research Scholar, School of Pharmaceutical Sciences, Shoolini University, Solan, (H.P), 173229
Brisha Bhardwaj2
2
Student, Himachal Institute of Pharmaceutical Education & Research (HIPER), Bela, Nadaun,
Hamirpur (H.P.), 177033
ABSTRACT
Tablets are used as formulation and are prepared by using plant extracts i.e., Carica papaya and Embelica
officinalis. These tablets were prepared by using wet granulation method. In this article the extract of leaves of
Carica papaya and fruits of Embelica officinalis were used for making herbal tablets. Extracts of leaves of Carica
papaya was obtained by cold extraction and through maceration method and the extract of fruits of Embelica
officinalis was obtained by maceration process. Both extracts were dried and mixed. These extracts were then
impregnated with the excipients like diluents, binding agents, super disintegrating agent, lubricants, etc. to make
granules. These granules were then evaluated by using various parameters like Angle of repose, tapped density,
bulk density, Carr’s Index, Hausner’s Ratio and void volume. These granules were then used for the making of
tablets of desired size and shape by punching in the machine. After preparation of the tablets their evaluation
parameters were studied like physical appearance, weight variation, friability, disintegration time, hardness test
and thickness. Also the parameters for the acceptance of the tablets is also done like flavor and sweetness. Recent
studies have shown that herbal extract of leaves of papaya has beneficial effect as an anti-inflammatory agent, for
its wound healing properties, anti-tumor as well as Immunomodulatory effects and as an antioxidant. Amla fruit
is a rich natural source of vitamin C (Ascorbic acid) and contains 600-750 mg/100 g of the fresh pulp. Also it is
rich in minerals matters like phosphorus, iron and calcium. Amla is used as an Immunomodulatory agent and
hence enhance the immunity of the patient. Aim of the study is to design develop and optimize the dosage form to
cure dengue and is based on the use of natural plant ingredients to intermingle with chemical as well as synthetic
ingredients to develop an effective unit dosage forms for better patient compliance.
KEYWORDS: Papaya, Amla, Extracts, Herbal tablet, Dengue, Immunomodulatory, Platelets.
1. INTRODUCTION
Medicinal plants are widely distributed throughout the world but most abundantly in tropical countries. It is a
mosquito-borne disease affected by infection of any anti-genically distinct dengue virus serotypes, belonging
from Flavivirus genus as well as Flaviviridae family, contain with single positive stranded RNA viruses. It is
estimated that about 25% of all modern medicines are directly or indirectly derived from higher plants. Thus,
herbal medicine has led to the discovery of a number of new drugs, and non-drug substances. To achieve the
desired benefit from herbal preparations, an individual must take the required dose over a certain length of time.
Although it is generally believed that most herbal preparations are safe for consumption, some herbs like most
biologically active substances could be toxic with undesirable side effects. 1
2. DRUG FORMULATION
2.1 Papaya: Carica papaya belongs to the fruits and vegetables class of family Caricaceae. The fruit are
popularly used as desert or processed into Jam, puree or wine, while the green fruits are cooked as vegetable. 2
Carica papaya leave (CPL) is used as food or as medication in folk medicine. Traditionally, the leaf extract was
used as a tonic for the heart, analgesia and treatment for stomach ache. The extract is also known to have
antioxidant properties but there are no scientific data reported on the protective effect of this extract on alcohol
induced acute gastric damage.3
Papaya is also known as the source of papain enzyme, a kind of enzyme that is utilized as meat
tenderizer. Papaya leaf extracts have phenolic compounds, such as protocatechuic acid, p-coumaric acid, 5,7-
dimethoxycoumarin, caffeic acid, kaempferol, quercetin, chlorogenic acid. These compounds have antimicrobial
activity and have been proven to be able to inhibit the growth of microbes. 4 The high level of natural self-
defense compounds in the tree makes it highly resistant to insect and disease infestation. 5 Carica papaya has
crown shaped large palmate leaves emerging from the apex of the trunk of the tree. The soft, hollow, cylindrical
trunk ranges from 30 cm in diameter at the base to about 5 cm in diameter at the crown. The leaves (especially
fallen ones) are used variously for the treatment of fevers, pyrexia, diabetes, gonorrhea, syphilis, inflammation
and as a dressing for septic wound.6 Recent studies have shown its beneficial effect as an anti-inflammatory
agent, for its wound healing properties anti-tumor as well as immunomodulatory effects and as an antioxidant. A
toxicity study (acute, sub-acute and chronic toxicity) conducted on Sprague Dawley rats administered with C.
papaya leaves juice revealed that it was safe for oral consumption. Safety studies based on OECD (Organization
of Economic Cooperation and Development) guidelines for acute, sub-acute and chronic toxicity conducted on
C. papaya extract and showed that it was found to be safe for human consumption. The leaves of papaya have
been showed to contain many active components that can increase total antioxidant activity in blood and reduce
lipid peroxidation level, such as paper chymopapain, cystatin, tocopherol, ascorbic acid, flavonoids, cyanogenic-
glycosides glucosinolates. The alkaloids, flavonoids, saponins, tannin, and glycosides are related with anti-
inflammatory activity. C. papaya leaves extract also found to have anti-bacterial effect, anti-tumor, and
immunomodulation activities. The leaf of C. papaya is categorized as nontoxic because it’s LD50 >15 g/kg body
weight. The leaves also contain cardiac glycosides, anthraquinones, carpaine, pseudocarpaine, phenolic
compounds.7
2.2 Amla: It is fresh as well as dried fruits of the plant Emblica officinalis or Phyllanthus emblica belonging to
family Euphorbiaceae.
Colour: Green color changes to light yellow or brick red at maturity
Odour: Odourless
Fruits are fleshy obscurely 4 lobed with 6-trygonus seeds. They are very hard and smooth in appearance.
Amla fruit is a rich natural source of vitamin C (Ascorbic acid) and Contains 600-750 mg/100 g of the fresh
pulp. Also it is rich in minerals matters like phosphorus, iron and calcium. It contain appreciable amount of
pectin. Fresh fruit contains about 75% moisture. It is found that the vitamin content of dried fruits is not lost
considerably. It may be due to the presence of tannins, which retards oxidation of vitamin C. Amla fruits are
largely used in Indian medicine. It is used as an acrid, diuretics, refrigerant, laxative, diarrheas and dysentery. It
is a popular ingredient of ‘Triphala’ and ‘Chyawanprash’.9 The anti-inflammatory response of E. Officinalis
extract has been well established and predicted mechanism for anti-inflammation is based on its function to
reduce lymphocyte proliferation and histopathological severity of synovial hyperplasia. 10
Description
Macroscopic
Drug consists of curled pieces of pericarp of dried fruit occuring either as separated single segment, 1-2
cm long or united as 3 or 4 segments, bulk colour grey to black, pieces showing a broad, highly shrivelled and
wrinkled external convex surface to somewhat concave, transversely wrinkled lateral surface, external surface
shows a few whitish specks, occasionally some pieces show a portion of stony testa (which should be removed
before processing); texture rough, cartilaginous and tough.
Microscopic
Transverse section of fruit shows epicarp consisting of a single layered epidermis cell appearing tabular
and polygonal in surface view; cuticle present; mesocarp cells tangentially elongated parenchymatous and
crushed differentiated roughly into peripheral 8 or 9 layers of tangentially elongated smaller cells, rest
consisting of mostly isodiametric larger cells with walls showing irregular thickenings; ramified vascular
elements occasionally present; stone cells present either isolated or in small groups towards endocarp ; pitted
vascular fibers, walls appearing serrated due to the pit canals, leading into lumen.
Powder
Fine powder shows epidermis with uniformly thickened straight walled isodiametric parenchyma cells
with irregular thickened walls, occasionally short fibers and tracheids. 11
Positive stranded encapsulated RNA virus, 3 structural protein genes: C, M, E & 7 NS protein genes
Dengue is an arthropod-borne viral disease carried by Aedes aegypti as the vector, caused by 4 possible viral
serotypes, namely, serotype 1, 2, 3, and 4 of the Flaviviridae family. There is no specific antiviral drug available
for the treatment of dengue infection. Each episode of infection is known to induce a life-long protective
immunity to the homologous serotype but confers only partial and transient protection against subsequent
infection by the other serotypes. Secondary infection is a major risk factor for Dengue Haemorrhagic Fever
(DHF) possibly due to antibody-dependent enhancement. A patient with dengue fever presents typically with
fever, headache, and rash known as the dengue triad. There are many other nonspecific signs and symptoms
associated with DF and patient can progress to DHF and typically manifests as abdominal pain, bleeding, and
even circulatory collapse. The clinical course of dengue has an abrupt onset followed by three phases, namely,
the febrile phase, the critical phase and the recovery phase. It is during the critical phase that thrombocytopenia,
characterized by a decrease in platelet count below 1,00,000/mm3 from the baseline and haemoconcentration,
characterized by an increase of haematocrit by 20% or more, is detectable before the subsidence of fever and the
onset of shock. Safety studies based on OECD guidelines for acute, subacute, and chronic toxicity were
conducted on C. papaya extract and showed that it was found to be safe for human consumption. The present
study was conducted to determine and investigate the traditional claim that CPLJ increases the platelet count in
patients with DF and DHF.13
These are some ingredients that are used in preparation of tablets which are useful in the treatment of dengue.
4.1.2 Evaluations of Granules
The evaluation parameters angle of repose, tapped density, bulk density, Carr’s Index, Hausner’s Ratio and Void
volume were carried out for the granules of F1 & F2 and are showed in the Table No. 2.
These are some evaluation parameters that are carried out for the granules used to manufacture dengue tablets.
These are some evaluation parameters that are carried out for the tablets that are manufactured for dengue.
4.2 Discussion
The preparation, evaluation and submission of the tables were done successfully. Three batches were
prepared that is, one is trial batch and others are drug containing batch F1 and F2. There were many differences
that are seen in the both of the formula of formulation F1 and F2. As in formula of both the batches to increase
their bulkiness different diluents are used. In F1, Lactose is used while in F2, Calcium Carbonate is used. In
formula also there is difference between the super disintegrating agent i.e., Sodium Starch Glycolate (SSG) in
both formulations, the amount of SSG is increased in F2. In F1, the use of Sodium Bicarbonate is done that will
decrease the tablet disintegration time. Papaya leaves extract is used to prepare the formulation because due to
Dengue the Platelet count in patient is decreased, it will increase the count. Amla fruit extract is used to increase
the immunity of the patient. The sweetening agents are also used to mask the bad taste. Also the flavoring agent
is used which will mask the bad odour too. The difference between the evaluation parameters of Granules is also
seen. Every evaluation parameter of F1 is Greater than the F2. The evaluation parameters of the tablets also
have difference in both F1 and F2. As in physical appearance, tablets of F1 is having brownish-black colour and
in F2, tablets are having brownish color. Acceptability test of both formulations indicates that they can be easily
taken by patients. Weight variation and friability of F1 is lesser than F2. Thicknesses of the tablets of both
formulations are same. Hardness and disintegration time of the F2 is lesser than as that of F1.
5 CONCLUSION
From all the results obtained and discussion observed, the conclusion is obtained that the tablets were
prepared for the Dengue was successful and that can be used for the treatment of the disease. In the
present study the extract of leaves of Carica papaya was used and fruits of Embelica officinalis were
used for making tablets. Extracts of leaves of Carica papaya was obtained by cold extraction and
through maceration. Extract of fruits of Embelica officinalis was obtained by maceration process.
These extracts were impregnated with the excipients like diluents, binding agents, lubricants to make
granules. These granules were used for making tablets of desired size and shape. Recent studies have
shown in the present study herbal extract of leaves of papaya has beneficial effect as an anti-
inflammatory agent, for its wound healing properties anti-tumor as well as immunomodulatory effects
and as an antioxidant. Amla fruit is a rich natural source of vitamin C (Ascorbic acid) and Contains
600-750 mg per 100 g of the fresh pulp. Also it is rich in minerals matters like phosphorus, iron and
calcium. It contain appreciable amount of pectin. It is found that the vitamin content of dried fruits is
not lost considerably. The two plants extract that have been used for the preparation the tablets are said
to be useful in the treatment of the disease. As, one extract i.e., Papaya leaves extract is used to
increase the platelet count in body and the other i.e., Amla fruit extract is used to increase the immunity
of the patient.
Present study may be used for as a novel approach for the treatment of Dengue infections. Tablets were
prepared successfully from the plant extract of Carica papaya and Embelica officinalis with appropriate
ingredients. Tablets were evaluated for different parameters showed satisfactory results. Results
showed that F1 formulation showed better Disintegration time as compared to F2 formulation with
other satisfactory parameters.
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