Phytochemical standardization, formulation and evaluation of oral hard gelatin capsules from Pinus eldarica bark extract.

Abstract

The extract of Pinus eldarica bark contains many polyphenolic compounds that were studied due to their high antioxidant, anti-inflammatory and anti-mutagenic effects. Therefore, the purpose of the present study was to conduct phytochemical standardization and develop hard gelatin capsules from the extract of P. eldarica bark. Extraction was carried out by maceration method at room temperature for 72 hr using ethanol 70% followed by freeze drying. Quantification and standardization tests were performed using Folin-Ciocalteu method. Then, nine formulations were prepared containing different amounts of stearic acid (1-3%) and corn starch (3%, 10%, and 25%). Each formulation was characterized by FTIR and pharmacopoeial tests such as drug content, disintegration time, flowability parameters and drug release percent. The optimized formulation underwent stability studies at 75±5% humidity and 40±2°C. The total phenolic content of the extract in terms of gallic acid equivalent was 362.8±5.4 mg/g and the total procyanidin content in the extract was 174.386±2.5 mg/g. FTIR revealed no interaction between the components. The results presented that the best formulation of the capsules was achieved they contained 3% of stearic acid and 25% of corn starch. This formulation showed 91.69±0.33% of drug content, 9.36±0.02 min disintegration time and 83.02±0.81% release percent. Moreover, it showed good flowability. Stability studies on the optimized formulation displayed that the formulation was stable within 6 months in the accelerated condition. In conclusion, results of the present phytopharmaceutical evaluations confirmed this product as a promising herbal capsule formulation.