Pilot Scale-Up Application of Gum from Prosopis Africana Family Mimosaceae (Guill And Perr.) Taub, As Binder in Tablet Technology

Abstract

In this study, kilograms of Prosopis afiicnna gum powder was processed from the ripe seeds of Prosopis apicnna, family Mimosaceae (Guill and Perr) Taub by boiling the seeds appropriately with purified water and later soaking with 1% "/v sodium metabisulphite solution. The gum was precipitated using suitable volumes of acetone that was later recovered and recycled for subsequent uses. The 250pm undersize (industrial grade) gum produced was used to granulate seven commonly used drug powders, namely, magnesium trisilicate, ascorbic acid, sodium bicarbonate, chlorpheniramine maleate, vitamin-B-complex, folic acid and paracetamol using the conventional wet-granulation technique. In order to make for industrial batch size, a lOkg quantity of the formulation was granulated in each case. Various small to large scale manufacturing equipment such as the Fitzmill granulator (Manesty, Liverpool) H-mixer (Rochdale, England) and tablet machines (Manesty Double Rotaly BB3B stations etc) were used in the granulation and tabletting stages of the work in particular. Detailed in viiro tablet control tests especially weight uniformity, dissolution rate, hardness, friability and disintegration times were carried out for the tablets under study. Similar batches containing corn starch used as the basis for comparison based on performance and economic cost of the widely used binder in the African-market were studied. In vitro drug release of the drugs for selected tablets, namely paracetamol, chlorpheniramine, ascorbic acid and (riboflavine from) vitamin-Bcomplex were studied for tablet batches containing Prosopis africana or corn starch respectively. The results obtained showed that the yield of the gum was 30% "/w of the dry seed and the overall cost estimate stood at N68 per kilogram. The powered gum remained stable over a period of three years as there was no loss in physical appearance and viscosity at predetermined pH and temperatures during preliminary studies. Within the first one year, all the tablets produced using either prosopis afrricana or corn starch as binder and stored in containers kept in the dark at ambient room temperature of 30* 2°C showed no deterioration in terms of physical appearance or any of the tablet properties including drug content. The t50% and t75% for the tablets containing either the test binder or the control were less than 30 minutes in the selected tablets. However faster release was observed in all cases for the control tablets containing corn starch as binder. When the selected tablets were retested after a period of three years storage at 30* 2°C in the dark, only paracetamol, ascorbic acid, chlorpheniramine maleate and the vitamin-B-complex tablets were judged acceptable in terms of physical appearance and drug content unlike the sodium bicarbonate, magnesium trisilicate and folic acid tablets where either loss of colour and flavor occurred. However in no case was the drug content found to decrease by more than 1 O%/w. Generally the tablets containing corn starch as binder were found to be more stable after a period of three years storage at ambient room temperature (30* 2°C) conditions.