2.  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

4.  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

5.  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.

6.  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

7.  To formulate Moringa oleifera leaf powder into an improved, well characterized oral dosage form

8. 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

9.  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

10.  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)

11. No_Material Mg/tablet F1F2F3F4 1Moringa powder 327.27 2Corn starch 32.73 (10% ) 40.91 (12.5%) 32.73 (10%) 3Gelatin3.27 (1%)16.36(5%)-- 4PVP (K- 30) --3.27 (1%)9.81 (3%) 5Lactose81.4968.4073.3174.95 6SLS1.64 7Talc0.33 8Magnesiu m stearate 3.27 Total weight 450

13. Dav (μm) P (g/ml) Db (g/ml) Dt (g/ml) RDε ɵ (°) HRCI 268.4751.354± 0.092 0.370.500.370.6338.31.3538.3

14. MaterialPercentage yield (% w/w) Chloroform extractEthanol extract M. oleifera leaf powder (100 g) 6.075.49 M. oleifera formulated tablet powder (100 g) 4.414.17

16. MicroorganismZones of inhibition (mm) Chloroform extract Methanol extract Gentamycin (+ve control) Negative control S. aureus13.929.0428.116.87 E. coli10.718.4526.107.07

18. MicroorganismZones of inhibition (mm) Chloroform extract Methanol extract Gentamycin (+ve control) Negative control S. aureus11.018.0727.576.90 E. coli11.028.7226.106.92

20. Micromeritic property MOPFormulations F1 granulesF2 granulesF3 granulesF4 granules Dav (μm)268.475368..54366.56363.48436.02 Ρ (g/ml)1.354±0.09 2 1.17±0.0721.16±0.0911.17±0.0821.18±0.092 Db (g/ml)0.370.480.490.480.50 Dt (g/ml)0.500.560.570.560.59 RD0.370.480.490.480.50 Porosity, ε0.630.520.510.520.50 ɵ (°) 38.337.037.5 37.7 HR1.351.171.161.171.18 CI (%)2614.2914.0414.2915.25

22. Formula tion No_ of tablets weighed Mean weight (g) Standard deviation No_ of tablets within range No_ of tablets outside range F1200.4470.012220Nil F2200.4710.007220Nil F3200.4540.010920Nil F4200.4450.012820Nil

23. Quality test Formulation F1F2F3F4 Hardness (N) 46.1±10.363.1±8.446.6±3.143.0±5.6 Friability (%) 0.670.430.670.23 Disintegrati on Time (min) 22.0533.5313.1518.61

25. Formula tion No_ of tablets weighed Mean weight (g) Standard deviation No_ of tablets within range No_ tablets outside range F1200.44850.01501703 F2200.45750.012020Nil F3200.44500.013020Nil F4200.44000.02641109

26. TestFormulation F1F2F3F4 Disintegrati on Time (min) 30.6250.4427.0037.31

27.  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

28.  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.

29.  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

30.  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.