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 AUTHOR- Musiba Baliruno Denis, B.

pharm (MUST)

SUPERVISORS;
 Prof. K.A.M. Kuria, PhD - Department of Pharmaceutics and
Pharmacy Practice, University of Nairobi.
 Dr. L.J. Tirop, PhD - Department of Pharmaceutics and
Pharmacy Practice, University of Nairobi
 Moringa oleifera leaves are rich in a number of nutrients.

 A wide range of pharmacological properties have been


reported for M. oleifera leaves.

 All M. oleifera leaf products are presented as bulk powders or


divided powders in manually filled capsules or as tea bags

 However, the presentation of these products has many


disadvantages
 Formulation of whole powders of herbal medicines in form of
conventional immediate release tablets

 In developing a new oral formulation, attention must be given


to factors that improve delivery of the drug delivery to the GIT

 The formulation and preparation of tablets with a high


percentage of active substances

 Fulfilling tablet hardness and disintegration time requirements

 Need for moisture protective coating.


 The use of Moringa oleifera products has become more
popular now than before for both its nutritional and medicinal
purposes

 However, the presentation of these products and their quality


profiles remain a major concern

 This study was therefore aimed at coming up with well


characterized film coated tablets of M. oleifera leaf powder
 To formulate Moringa oleifera leaf powder into an improved,
well characterized oral dosage form
General objective;
 To formulate and evaluate film coated tablets of Moringa
oleifera leaf powder

Specific objectives;
 To granulate Moringa oleifera leaf powder

 To compress the prepared granules into tablets

 To carry out film coating of the resultant tablets

 To evaluate the quality of M. oleifera film coated tablets


 Research Design: experimental study

 Study site: Department of Pharmaceutics and Pharmacy


practice, University of Nairobi, Kenya.

 Equipment: tablet compression machine (Erweka, electric


type Germany), Disintegration test machine (Erweka ZT3,
GmbH Heusenstamm, Germany), Friability test machine
(Erweka, Heusenstamm, type TA3R, Germany) and a coating
pan (Gryphon class E, N_150445R, England
 Materials: M. oleifera leaf powder was obtained from Kates
organic, Nairobi, Kenya. The other materials (excipients) were
obtained as a donation from Lab and Allied Ltd, Nairobi, Kenya.

 Preformulation studies: Moisture loss on drying, particle size


analysis, powder particle density, bulk, tapped and relative
density, angle of repose, Hausner’s Ratio (HR), Compressibility
index (CI) and antimicrobial assay

 Processes: extraction, granulation, tablet compression, film


coating and tablet tests (uniformity of weight, hardness,
friability, disintegration and antimicrobial activity test)
No_ Material Mg/tablet
F1 F2 F3 F4
1 Moringa 327.27 327.27 327.27 327.27
powder
2 Corn 32.73 32.73 40.91 32.73
starch (10% ) (10%) (12.5%) (10%)
3 Gelatin 3.27 (1%) 16.36(5%) - -
4 PVP (K- - - 3.27 (1%) 9.81 (3%)
30)
5 Lactose 81.49 68.40 73.31 74.95
6 SLS 1.64 1.64 1.64 1.64
7 Talc 0.33 0.33 0.33 0.33
8 Magnesiu 3.27 3.27 3.27 3.27
m stearate
Total 450 450 450 450
weight
Dav P Db Dt RD ε ɵ (°) HR CI
(μm) (g/ml) (g/ml) (g/ml)
268.475 1.354± 0.37 0.50 0.37 0.63 38.3 1.35 38.3
0.092
Material Percentage yield (% w/w)
Chloroform extract Ethanol extract
M. oleifera leaf 6.07 5.49
powder (100 g)
M. oleifera 4.41 4.17
formulated tablet
powder (100 g)
Microorganism Zones of inhibition (mm)
Chloroform Methanol Gentamycin Negative
extract extract (+ve control) control
S. aureus 13.92 9.04 28.11 6.87
E. coli 10.71 8.45 26.10 7.07
Microorganism Zones of inhibition (mm)
Chloroform Methanol Gentamycin Negative
extract extract (+ve control) control
S. aureus 11.01 8.07 27.57 6.90
E. coli 11.02 8.72 26.10 6.92
Micromeritic MOP Formulations
property F1 granules F2 granules F3 granules F4 granules
Dav (μm) 268.475 368..54 366.56 363.48 436.02
Ρ (g/ml) 1.354±0.09 1.17±0.072 1.16±0.091 1.17±0.082 1.18±0.092
2
Db (g/ml) 0.37 0.48 0.49 0.48 0.50
Dt (g/ml) 0.50 0.56 0.57 0.56 0.59
RD 0.37 0.48 0.49 0.48 0.50
Porosity, ε 0.63 0.52 0.51 0.52 0.50
ɵ (°) 38.3 37.0 37.5 37.5 37.7
HR 1.35 1.17 1.16 1.17 1.18
CI (%) 26 14.29 14.04 14.29 15.25
Formula No_ of Mean Standard No_ of No_ of
tion tablets weight deviation tablets tablets
weighed (g) within outside
range range
F1 20 0.447 0.0122 20 Nil
F2 20 0.471 0.0072 20 Nil
F3 20 0.454 0.0109 20 Nil
F4 20 0.445 0.0128 20 Nil
Quality Formulation
test F1 F2 F3 F4
Hardness 46.1±10.3 63.1±8.4 46.6±3.1 43.0±5.6
(N)
Friability 0.67 0.43 0.67 0.23
(%)
Disintegrati 22.05 33.53 13.15 18.61
on Time
(min)
Formula No_ of Mean Standard No_ of No_
tion tablets weight deviation tablets tablets
weighed (g) within outside
range range
F1 20 0.4485 0.0150 17 03
F2 20 0.4575 0.0120 20 Nil
F3 20 0.4450 0.0130 20 Nil
F4 20 0.4400 0.0264 11 09
Test Formulation
F1 F2 F3 F4
Disintegrati 30.62 50.44 27.00 37.31
on Time
(min)
 From preformulation studies, the moisture loss on drying of
M. oleifera was less than the accepted maximum and this can
inhibit bacterial, fungal and yeast growth
 The preformulation studies also indicated the powder as
having poor flow properties
 Antimicrobial activity of the powder was consistent with
results of previous studies and this activity was also exhibited
by the formulated tablets
 Granules of four different formulations were rated as having
good flow properties based on CI and HR and fair based on
angle of repose
 All the formulated uncoated tablets passed uniformity of
weight test, hardness test and friability test. Only formulation
F3 uncoated tablets passed disintegration test

 Of the film coated tablets, only F2 and F3 passed uniformity


of weight test. Manual spraying could have caused variations
in the coating thickness and hence the discrepancy.

 Only F3 film coated tablets passed the disintegration test.


Tablets of the rest of the formulations disintegrated beyond the
stipulated 30 minutes for film coated tablets.
 Moringa oleifera leaf powder has antimicrobial activity which
is retained upon being formulated into tablets
 Granules M. oleifera leaf powder formulated with 1% PVP as
binder and 12.5% corn starch as disintegrant posses good flow
properties and their resultant tablets are strong enough to pass
friability test and at the same time pass disintegration test
 Film coating improves the appearance of M. oleifera tablets
and also reduce dusting.
 All in all, film coated tablets of M. oleifera leaf powder can
be formulated with 1% PVP as binder and 12.5% corn starch
as disintegrant
 Determination of tablets strength(dose size) was arbitrary due
to lack of clinical data.

 Therefore, further research should be done to establish the


above before M. oleifera film coated tablets can be scaled up
to commercial production.