Formulation of Lippi alba (Verbenaceae) leaves capsules for the treatment of high blood pressure

High blood pressure is a real public health issue, affecting around 1.13 billion people worldwide. The World Health Organization (WHO) reports that less than 20% of people with high blood pressure are properly managed medically. The most common treatments are based on the use of diuretics, calcium channel blockers, beta blockers, and alpha blockers. However, due to the relatively high cost of antihypertensive drugs, the search for new alternatives is becoming a necessity. Lippia alba is known for its antispasmodic, analgesic, sedative, anxiolytic, and antihypertensive properties. These properties and the empirical use of the plant in the form of an infusion make it a potentially interesting herbal drug to develop. This study aimed to formulate capsules from Lippia alba leaves to improve the management of high blood pressure. To do this, the Lippia alba leaves were crushed and then infused in drinking water. The amount of extract needed to manage high blood pressure was determined in milligrams of gallic acid equivalent of total polyphenols per gram of extract. Several formulas were prepared by mixing the aqueous extract of Lippia alba leaves with suitable excipients. The capsules were also tested in accordance with the techniques described in the 11th edition of the European Pharmacopoeia. The extract was dark brown in color, very bitter, and had an aromatic odor; it was obtained with a yield of 18.60%. The polyphenol content was 175 mg gallic acid equivalent per gram of extract. The following excipients were used to formulate the capsules: colloidal anhydrous silica (Aerosol* 300), microcrystalline cellulose (Avicel*PH-102, PH-101), dicalcium phosphate (Fuji Calin*), ready-to-use lactose-polyvinylpyrrolidone K30-crospovidone (Ludi press*) LCE mixture. The chosen unit formula had good flow properties (3 seconds for 100g of powder), a Carr index of 14.80% and a Hausner index of 1.17. The powder was homogeneous and moderately fine (d50 < 300 am). Each size 0 capsule contains 364.5 mg of crude extract corresponding to 63.8 mg gallic acid equivalent of polyphenols, 73 mg of Ludi press* LCE, and 48.5 mg of Fuji Calin*. The daily dose determined for a 60 kg adult was 729 mg of extract, corresponding to 127.6 mg gallic acid equivalent of total polyphenols, which can be divided into 2 capsules for one day. The results of the physicochemical and pharmaceutical tests carried out on the capsules were found to comply with the specifications of the 11th edition of the European Pharmacopoeia. The characteristics of these capsules make them a good candidate for development into an improved traditional medicine (ITM).