Volume 9, Issue 4, April – 2024 International Journal of Innovative Science and Research Technology

ISSN No:-2456-2165 https://doi.org/10.38124/ijisrt/IJISRT24APR295

Formulation and Evaluation of Polyherbal

Hematinic Capsule for Pediatrics
Tadikonda Rama Rao1; Aditya Anand2
Professor and Principal1,
Department of Pharmaceutics
CMR College of Pharmacy Hyderabad, Telangana, India

Abstract:- Hematinic deficiencies in children, including frequently tainted and do not adhere to the standards set
those related to iron, folic acid, and vitamin B12, are a forth for legitimate drugs. The majority of conventional
serious health issue that impact a child's growth, medical systems work well, but they are not standardized,
development, and general wellbeing. Administration of hence a method for standardization must be created. To
dose, taste, and compliance are common problems with standardize these traditional formulas, the Central Council
conventional therapies. To address these issues, the of Research in Ayurveda and Siddha has produced
production and testing of polyherbal hematinic capsules preliminary recommendations. In order to ensure batch
intended for pediatric usage is the main focus of this homogeneity in the manufacturing of herbal formulations,
work. Strong hematinic properties in plant extracts are assessment methodologies must be developed (3). Drugs
selected with care, and the right processing methods are identities are implied by their standardization, which also
used for young users. The capsule size is adjusted for ensures their purity and quality. At first, the only way to
ease of swallowing, and the polyherbal mixture is identify the raw medications was by comparing them to the
improved to increase compliance. To ascertain the standard description. The active ingredients and physical
effectiveness, safety, and suitability for use in pediatric constants of crude pharmaceuticals are currently estimated
settings, testing is done. The created polyherbal using a variety of techniques, including botanical,
hematinic capsules exhibit outstanding disintegration chemical, spectroscopic, and biological approaches, as a
time, flow characteristics, and an hourly cumulative result of the growing awareness of the chemical makeup of
drug release of 97.7%. The results imply that hematinic raw medications (2).
polyherbal capsules have potential as a safe and
efficient option for treating paediatric hematinic The present study is aimed to formulate polyherbal
deficits, addressing compliance concerns and providing capsules using the leaves extract of Psidium guajava,
an appealing dose form. Trigonella foenum-graecum, Cymbopogon citratus,
Moringa oleifera and bark extract of Mangifera indica and
Keywords:- Hematinic; Polyherbal; Extract; Pediatric; evaluate the same as given to treat haematopoiesis disease
Disintegration in pediatrics.

I. INTRODUCTION Anaemia is a frequent nutritional deficiency illness

that has serious implications for human health as well as
The World Health Organization (WHO) has approved the social and economic development of both developing
medical goods based on limited medicinal herbs labelled and industrialized nations. It is a global public health
with active substances, plant materials or mixes of concern (WHO 2005). Over 2 billion people, or one-third
materials, aerial or subterranean sections of the plant, or of the world's population, suffer from anemia as a result of
other plant components (1). Polyherbal formulations are an imbalance in their intake of nutrient-dense foods,
those that include two or more natural medicines with according to WHO statistics from 2004 (4,5,6).
distinct pharmacological activities and therapeutic effects.
Herbal treatments are now widely used as medicinal agents The process that produces all of the cellular
for a wide range of illnesses, including diabetes, constituents of blood and blood plasma is known as
rheumatoid arthritis, liver disease, cough treatments, and haematopoiesis. The hematopoietic system (as shown in the
memory boosters (2). Considering the medicinal qualities Fig. 1), which consists of tissues and organs like the liver,
associated with a tough medicine, it is critical to preserve spleen, and bone marrow, is where it takes place. It starts
its excellence and integrity in the company's portfolio. The long before birth, early in an embryo's development, and
fact remains, nevertheless, that the drugs being sold are lasts the entirety of an individual's life (7,8).

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Volume 9, Issue 4, April – 2024 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165 https://doi.org/10.38124/ijisrt/IJISRT24APR295

Fig 1: Diagram Showing the Development of Different Blood Cells from Haematopoietic Stem Cell to Mature Cells

(A)Psidium (B) Moringa Oleifera (C) Cymbopogon Citratus

(D) Mangifera Indica (E) Trigonella Foenum-Graecum

Fig 2: Collected Powdered Herbal Raw Materials

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Volume 9, Issue 4, April – 2024 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165 https://doi.org/10.38124/ijisrt/IJISRT24APR295

II. MATERIALS AND METHODS graecum, Cymbopogon citratus, and Moringa oleifera were
coarsely powdered in a shaded area and placed in a Soxhlet
The plant parts selected were all available in and apparatus. The mixture was then extracted using petroleum
around the locality, they were collected in person from the ether (60–62°C), chloroform, ethanol, and water until the
respective during the Months of APRIL-JUNE, 2023.The extraction process was completed. Following the success of
procured plant materials were washed thrice in running extraction, the solvent was eliminated by distillation. Using
water, and cleaned thoroughly. They were then dried under a rotator evaporator, the extracts were dried. Following
shade for a week or so. Once they were completely dried, storage of the residue in a desiccator, the yield % was
they were ground into coarse powder (as shown in the determined.
Figure 2), and stored in air tight containers and preserved
for the further processing. B. Organoleptic properties of Collected Raw Materials :
This study evaluates organoleptic characteristics of
A. Extraction of Plant Material : plant materials, including physical appearance, taste, and
Samples of both the bark and the leaves were broken odour (as shown in Table 1), to establish quality and
up and put through a 40 mesh sieve. The bark of Mangifera determine the degree of quality through sensory organs.
indica and leaves of Psidium guajava, Trigonella foenum-

Table 1: Organoleptic Properties of Collected Herbs

S.No. Name of the Plant Nature Colour Odour Taste
1. Mangifera indica (bark) Coarse powder Light brownish Odourless Tasteless
2. Psidium guajava (leaves) Coarse powder Dull green Odourless Slightly bitter
3. Trigonella foenum-graecum (seeds) Coarse powder Yellowish Pungent Bitter
4. Cymbopogon citratus (leaves) Coarse powder Dark green Pungent Sour
5. Moringa oleifera (leaves) Coarse powder Dull green Odourless Bitter

III. RESULTS AND DISCUSSION mill, and they were then dried and weighed every hour. The
samples were kept in the drying chamber (105°C) for 5
A. Preliminary Quality Control of Collected Raw hours and values were noted down as shown in Table 2.
Materials:
Loss on drying % = final weight of the sample/ initial
 Loss on Drying weight of the sample × 100.
10 g of the sample materials (without initial drying)
were taken and put in a tarred evaporating dish. The
samples were prepared without the use of a high-speed

Table 2: Loss on Drying Values of the Powders.

S.No. Name of the Plant LOD (% w/w) Acceptable Limits (%W/W)
1. Mangifera indica (bark) 4.38±0.75 NMT 8
2. Psidium guajava (leaves) 3.12±0.68 NMT 6
3. Trigonella foenum-graecum (seeds) 4.23±1.25 NMT 5
4. Cymbopogon citratus (leaves) 3.45±1.12 NMT 8
5. Moringa oleifera (leaves) 4.34±0.89 NMT 5
The value are expressed as mean ± SD, (n=3); NMT-Not more than

B. Calibration Curve of Poly Herbal Extract in 0.1N HCL absorbance was measured and noted (as shown in Table 3),
Buffer: using a UV visible spectrophotometer. A linear graph of
A working stock of 1000 µg/ml was prepared by absorbance Vs concentration was plotted (as shown in
dilution of polyherbal extract in pH 1.5 HCL buffer. Figure 3), confirming compliance with Beer's law over a
Primary and secondary dilutions were created, and range of 2-10 µg/ml.

Table 3: Calibration Data of Polyherbal Extract.

S.No. Concentration (µg/ml) Absorbance (nm)
1. 0 0
2. 2 0.138
3. 4 0.241
4. 6 0.346
5. 8 0.453
6. 10 0.552

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Volume 9, Issue 4, April – 2024 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165 https://doi.org/10.38124/ijisrt/IJISRT24APR295

Fig 3: Calibration Curve of Polyherbal Extract

C. Formulation of Dosage Forms

The formulation contained the herbal extracts of
Psidium guajava, Trigonella foenum-graecum,
Cymbopogon citratus, Moringa oleifera and Mangifera
indica and various grades of HPMC polymers (HPMC K15,
HPMC K4M, HPMC K100) were prepared in the varied ratio
(as mentioned in Table No. 4). The formulation quality was
assessed in accordance with WHO criteria for herbal
material quality control. In accordance with the
recommendations, detailed analyses of powder
characteristics, including bulk density, tapped density,
angle of repose, and so forth, were conducted, and
noteworthy findings were documented. Fig 4: Formulated Polyherbal Hematinic Capsules

Table 4: Composition of the formulated Dosage Form

S.No. Materials F1 (mg) F2 (mg) F3 (mg)
1. Mangifera indica 4 4 4
2. Psidium guajava 4 4 4
3. Trigonella foenum-graecum 4 4 4
4. Cymbopogon citratus 4 4 4
5. Moringa oleifera 4 4 4
6. Micro crystalline cellulose 30 30 30
7. Starch q.s. q.s. q.s.
8. HPMC K15 10 __ __
9. HPMC K4M __ 10 __
10. HPMC K100 __ __ 10
11. Magnesium carbonate 3.5 3.5 3.5
12. Sodium methyl paraben 1.5 1.5 1.5

The ethanolic extracts were freeze-dried before being D. Preformulation Studies

used in a formulation procedure. The dried herb extracts Preformulation parameters such as bulk density,
were weighed and combined to create 20 mg of extract. tapped density, compressibility index, hausner’s ratio, angle
Magnesium carbonate was added for adsorption. The of repose were performed and the values were noted down
mixture was then triturated and sieved. Preformulation as shown in Table 5.
experiments were conducted on the obtained fine powder.

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Table 5: Preformulation Studies of Obtained Formulation

Parameters F1 F2 F3
Bulk density (g/cm2) 0.70±0.04 0.55±0.01 0.9±0.05
Tapped density(g/cm2) 0.71±0.02 0.61±0.04 1.04±0.04
Compressibility index (%w/w) 17.5±0.63 19.1±0.46 14.7±0.04
Hausner's Ratio 1.14±0.13 1.17±0.15 1.12±0.13
Angle of repose (degrees) 32.32±0.06 34.02±2.46 30.04±3.62
The value are expressed as mean ± SD, (n=3); NMT-Not more than

E. Development of Dosage Form (Capsule) by Wet placed into labeled poly bags (as shown in Fig. 4). Samples
Granulation Method: were then assessed in accordance with the testing
Trials were conducted to determine the best ratio of specifications. The extracts of Psidium guajava, Trigonella
binders to use, as well as the amount of lubricants and foenum-graecum, Cymbopogon citratus, Moringa oleifera,
preservatives to add before the process was finally refined. Mangifera indica, and Microcrystalline cellulose, together
The polyherbal extract was combined in the ratio shown in with excipients: quantity sufficient (q. s.), were present in
Table No. 4 after being finely powdered (sieve 40). further every 65 mg of polyherbal capsules, as indicated in Table
used to prepare capsules using the wet granulation method No. 4.
with a lactose solution acting as a binder. To get granules,
the moist bulk was run through filter number 22. The E. Evaluation Of Finished Product (Capsules) :
granules were dried at 45°C in a tray dryer. The grains were The developed polyherbal capsules were assessed
greased or lubricated with magnesium stearate. based on their description, weight uniformity,
Preservatives and diluents were used. disintegration time, moisture content, pH and dissolution
profile and the values were noted down as shown in Table
Following this, a capsule filling machine was used to 6. Indian Pharmacopeial standards were followed in order
fill the yellow-green, size "5" capsules with the improved to determine the weight uniformity.
batch's granules. After that, the capsules were removed and

Table 6: Physical parameter values of the obtained finished product

S.No. PARAMETER OBSERVATION
F1 F2 F3
1 Description Dull brown powder Dull brown powder Dull brown powder
contained in Green cap/ contained in Green cap/ contained in Green
yellow body “5” size yellow body “5” size cap/ yellow body “5”
capsule capsule size capsule
2 Colour Light brown Light brown Light brown
3 Odour Pungent Pungent Pungent
4 Taste Mint flavour Mint flavour Mint flavour
5 pH (1% aqueous solution) 7.33±0.21 7.41±0.32 7.4±0.22
6 Moisture content 17 ± 0.7 25±0.76 13±0.25
7 Uniformity of weight 61.2±0.88 63.3±0.98 65.7±0.97
8 Disintegration time 27’10 sec. 20’15 sec. 13 min.

 In-Vitro Drug Release Studies of Obtained Capsules withdrawn every 10 minutes, and absorbance was measured
The study conducted in-vitro dissolution studies for at 220nm (as shown in Table 7), using UV Visible
Polyherbal hematinic capsules using USP apparatus type I spectrophotometer. Cumulative drug release (%CDR) was
at 50 rpm and pH 1.5 HCL buffer. Samples were determined and a graph was plotted as shown in Figure 5.

Table 7: Cumulative Drug Release Studies of Formulations (F1-F3)

Time intervals (min) % Cumulative Drug Release
F1 F2 F3
10 3.7±0.08 4.8±0.21 8.14±0.5
20 20±0.12 21.3±0.12 24.4±0.17
30 34±0.13 40±0.07 44.7±0.38
40 51±0.22 61.7±0.1 69.2±0.47
50 58.3±0.19 68.4±0.12 81.4±0.87
60 66.5±0.076 85±0.42 97.7±0.67
Results are reported as Mean ± Standard deviation (n=3)

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Fig 5: In-Vitro Dissolution Studies of Formulated Polyherbal Capsules

Based of the faster release rate of Formulation-3 F. Drug Release Kinetics Study For in-Vitro Dissolution
capsules, it proves to be the best optimised formulation for Studies
drug kinetics study. Hence the kinetic study of all the Kinetic studies were performed for the formulations
formulations was done and the values obtained were noted and the values were noted down as shown in Table 8, and
down. the graphs are plotted as shown in Figure 6.

Table 8: Drug Release Kinetics for Formulations (F1-F3).

Formulation Zero order First order Higuchi Korsmeyer- peppas
R2 R2 R2 n R2
F1 0.9806 0.9653 0.8744 1.0935 0.937
F2 0.9826 0.9487 0.8578 1.1367 0.9551
F3 0.9883 0.9249 0.8623 1.1507 0.9866

Fig 6: Drug Release Kinetics of zero Order, First Order, Higuchi and Peppas Model

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IV. CONCLUSION [7]. Weatherall, D.J. Thalassemia in the next

millennium. Ann N Y Acad Sci. 1998;850:1-9.
Therefore this study is an attempt to formulate and DOI : https://doi.org/10.1111/j.1749-
evaluate the folklore claims of five indigenous herbs viz., 6632.1998.tb10456.x.
Mangifera indica (bark), Psidium guajava (leaves), [8]. Jaiswal S, Ebert BL. Clonal hematopoiesis in human
Trigonella foenum graecum, Cymbopogon citratus, aging and disease. Science.
Moringa oleifera ,as capsules for the treatment of anaemia. 2019;366(6465):eaan4673. DOI :
The selected plant powders were subjected to preliminary https://doi.org/10.1126/science.aan4673..
evaluation. The physio-chemical constants like ash values,
loss on drying, were performed. The results obtained
proved the procured raw materials were of good standard.
The phytochemical constituents were noted based on
previous works on these herbs. The presence of Iron,
flavonoids, vitamins and some proteins give favourable
effects to use these herbs in this formulation.

The drug release was affected by the concentration of

HPMC K15, HPMC K4M, and HPMC K100. The
concentration of HPMC K15 also controls the drug release.
The herbal raw materials were analysed for identity, quality
and purity as per the standards prescribed by WHO and
Ayurvedic Pharmacopeia of India.

The dried polyherbal extract was optimized for its

quality measures and its batch consistency by making three
different formulation batches. The formulated polyherbal
hematinic capsules of F3 showed excellent flow property,
disintegration time with controlled release and showed
97.7% of cumulative drug release within an hour of time.
Optimised formulation F3 was observed to follow zero
order kinetics.

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