Evaluation of oil extract from T. catappa as a sustained release injection base

Terminalia catappa seed oil with the following parameters: specific gravity-0.9200 ± 0.10, refractive index-0.4640 ± 0.06, viscosity (cps)-36.80 0.94, peroxide value-8.63 ± 0.03, saponification value-157.8 ± 2.88), iodine value-38.63 ± 1.06 was used to formulate haloperidol in injection dosage form of 10 mg/2 ml. The formulation was evaluated for content of active ingredient, stability, toxicity, physicochemical properties and release patterns through dialysis membrane in phosphate buffer at physiologic pH of 7.4. The results were compared with those of a standard haloperidol injection B.P. Active ingredient content was found to be 100.61± 0.38 and 101.29 ± 0.64 percent (%) for the oil injection and the B.P formulation, respectively. They all showed requisite sterility as no organisms were isolated after incubation for seven (7) days in appropriate media and temperature. However, there was a significant delay in the release of haloperidol from the oil injection as against the standard B.P injection (P<0.05). The haloperidol oil injection exhibited sustained release behavior and had a predicted shelf life of 2.66 years compared to the 1.65 years evaluated for the haloperidol injection B.P