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)
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
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
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
TestFormulation F1F2F3F4 Disintegrati on Time (min) 30.6250.4427.0037.31
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.