The Use Of Papaya Pulp Powder In The Formulation Of Tablets Containing Cefadroxil

S. Kuppusamy* ,T. K. Ravi, and Prasobh G. R
College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences,Sidhapudur, Coimbatore-641044 , India
* For correspondence

ABSTRCT

An attempt was made to identify the use of a natural product papaya pulp powder as a disintegrating agent in the formulation of cefadroxil dispersible tablets. To establish this two other commonly used disintegrating agents sodium starch glycolate, pre gelatinized starch were selected and formulated for comparison. Nine different formulation were prepared using the above three disintegrants in the concentration 8%,10%,12%. All the formulations were subjected to Invitro evaluation and the results were compared. The formulation containing papaya  pulp powder in the concentration 12%showed good dissolution and disintegration characteristics which were within the pharmacopoeial limits.

INTRODUCTION

Cefadroxil is an antibacterial used in the treatment of susceptible infections of the respiratory or urinary tracts^3,4.

Dispersible tablets are uncoated tablets intended to be dispensed in water before administration giving a homogenous dispersion ^3,4. The tablets produced must have the ability to form adequate dispersion which is uniform and stable when placed in water. The chief advantage is quicker absorption and onset of clinical effects. They are generally prepared for geriatric or pediatric patients or for those who are having difficulty in swallowing tablets²⁰. They comprise of totally water soluble excipients and components¹. Though the dispersible tablets of cefadroxil is available commercially the present study is undertaken with the objective of developing tablets with a natural product papaya pulp powder as a disintegrating agent.

MATERIALS & METHODS (EXPERIMENTAL)

MATERIALS

Cefadroxil (Osaka Pharmaceuticals Ltd),Maize starch, Sodium starch glycolate, Microcrystalline cellulose (Loba Chemi Pvt Ltd),Pregelatinised starch (SD Fine Chemicals Ltd), Talc (Indian Research Product Pvt Ltd)

METHOD

Dispersible tablets of cefadroxil were prepared by direct compression method. Nine formulation f1 to f9  were formulated using Sodium starch glycolate, Pregelatinised starch and a natural product papaya pulp powder in varying concentration 8%,10%,12% along with other additives like starch used as a binder, Microcrystalline cellulose used as a diluent, Magnesium stearate and talc as lubricants. These were mixed uniformly .The blend is then compressed into tablets of hardness 3-5 kg/sq.cm. The tablets are then evaluated for hardness, friability, dissolution, disintegration, weight variation test and uniformity of dispersion.

RESULTS

Hardness of the tablet was determined using Pfizer hardness tester and it was found to be in the range of 3-5kg/sq.cm.Friablilty was estimated using Roche Friabilator. The evaluation results for Friability, weight variation were within the official limits. In the test for  uniformity of dispersion all the formulations passed through sieve no:22.Dissolution studies were done using water as the medium at 37+0.2°C in Paddle apparatus. The amount of active ingredients were determined spectrophotometrically at 263nm.Disintegration was done using water as the fluid. All the formulation disintegrated within 3min fulfilling the official requirement.

Among the nine formulations it was found that f3 containing sodium starch glycolate in the con 12% showed better dissolution and disintegration characteristics Nevertheless formulation f9 containing papaya pulp powder as a disintegrating agent showed good disintegration and dissolution characteristics which were found to be within the limits for dispersible tablets specified in the pharmacopeias. By modifying the papaya pulp powder or by varying its concentration the characteristics of the powder can be improved.

Stability studies were done on all the formulation according to the ICH Guidelines. Accelerated storage conditions were maintained for 6months at 40°C.This was then compared with formulations kept at room temperature. It was found that all the formulations were stable at room temperature but a slight degradation at 40°C which were acceptable.

Table I : Formulation of Cefadroxil dispersible tablets

Table II : Evaluation results for disintegration Time, Hardness and dissolution
test

ACKNOWLEDGEMENT

The authors are grateful to Osaka Pharmaceuticals  for providing the gift sample and to Sri Ramakrishna College of pharmacy for providing necessary facilities for carrying out the research work.

REFERENCES

1. Indian Pharmacopoeia, Govt of India, Ministry of Health and Family Welfare ; Controller of Publication (Delhi) (1996) Vol II, Pg 735.

2. British Pharmacopoeia (2003), Vol III, Pg 2052.

3. The theory & practice of Industrial Pharmacy, Lean Lachmenn, Herbert A. Lieberman, Joseph L. Kanig, Pg 293-303.

4. S. Nazma  ; et.al ; The Indian Pharamcist (2004), Pg. 67-77.