FORMULATION AND ENCAPSULATION MACHINE DEVELOPMENT FOR NON- GELATIN SOFT CAPSULE OF RED GINGER EXTRACT HERBAL MEDICINE

• Main Author: Nyoman Wiwik Sutrisni, Ni
• Format: Dissertations
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/42885
• Institution: Institut Teknologi Bandung

Soft capsule is oral dosage form that filled with liquid, suspension or semisolid encapsulated by appropriate shell as one of unit dosage. Soft capsule gives better acceptance for the patient due to its esthetic and easiness to consume. Those advantages of soft capsule make it a suitable dosage form for herbal medicine. This study aimed to develop a formulation and encapsulation machine for non-gelatid soft capsule filled with red ginger extract as herbal medicine. A non-gelatine soft capsule was developed to overcome the drawback of gelatine which is animal source polymer that has limited acception regarding “halal”issue and unaccepted by vegetarian. Soft gelatine shell formulation was used as reference shell specification during development of nongelatine shell. This formulation contained of 45% of gelatine, and combination of glycerin and sorbitol liquid as plasticizer. The polymer melted at 60 - 70°C, the mass viscocity at 40°C was 50,800 cps. The mechanical characteristics of film with 0.75 mm of thickness were 13.07 ± 0.00 Mpa, 266.68 ± 13.392% and 4.91 ± 0.248 Mpa for stress, strain and modulus young respectively. Gelatine film has elastic characteristic and viscocity of mass relatively low. This study was focused on formulation of combination of ?-carrageenan and konjac glucomannan that gave higher film’s elasticity compared to film with single ?-carrageenan or combination of ?-carrageenan and maize starch. Combination of ?-carrageenan and konjac glucomannan in ratio of 4:1 with sodium carbonate as source of counter ion and glycerin-sorbitol solution as plasticizer prospective to be nongelatine formulation however it has higher melting temperature and mass viscocity. Thermal analysis using DSC showed 0.002% concentration of sodium carbonate resulted lower the glass transition temperature from 39.6°C to 37.0°C and showed exothermic peak similar to formulation without sodium carbonate. Exceed concentration of sodium carbonate up to 0.10% caused increasing of film crystalizaation and increased the glass temperature transition that effect on lower elasticity of film. The prospective film formulation was formula with 0.002% sodium carbonate as counter ion. Optimatizion of shell formulation was conducted using 2 full factorial design of experiment. Three factor were evaluated on film formulation based on combination of ?-carrageenan with konjac glucomannan i.e concentration of counter ion (sodium carbonate in range of 0.002 –0.05%); concentration of polyol as plasticizer (combination of glycerin and sorbitol solution in range of 10 –25%), and ratio of polymer (?- carragenan and konjac glucomannan in ratio of 4.5:0.5 and 4:1). Responses that evaluated were mass viscocity, disintegration time and elasticity of the film. The mass viscocity was mostly affected by concentration of polyol and interaction of counter ion concentration with polymer ratio. The disintegration time of film was affected by interaction between polyol concentration with polymer ratio and by polyol concentration. The film elasticity was affected by concentration of polyol and counter ion. In applied ratio of polymer combination, concentration of polyol has higher effect compare to the concentration of counter ion. This result might be caused of higher concentration of polyol and weak bonding strength of ion Na + with SO3 2- from sulphate function of ?-carrageenan. The highest film elasticity was produced when low concentration of polyol and high concentration of counter ion was applied but it results increasing of disintegration time of the film. Selected formula was combination ?-carrageenan with konjac glucomannan in ratio 4:1, 0.002% of sodium carbonate, 12% of glycerin and 7.5% of sorbitol liquid. Red ginger extract is oleoresin produced from rhizome of Zingiber officinale Rosc var rubrum contained 10% total of gingerol and shogaol. This oleoresin was viscous brown liquid with pungent odor and incompatible with water or crodamol. This extract can be solubilized in Virgin coconut oil (VCO) with ratio of 250:75. Assay of 6-gingerol and 6-shogaol contained in the mixture was conducted using High Pressure Liquid Chromatography (HPLC) with UV detector and gradient system. Test of method selectivity showed that VCO did not interrupt the peak on retention time of 6-gingerol and 6-shogaol in the mixture. Retention time were 8.8 minutes and 19.4 minutes for 6-gingerol and 6-shogaol respectively. The analytical method validation showed the method meet the specificity, linearity, accuracy, presission and robustness requirements. The compatibility study of film formulation and mixture that conducted in room temperature showed no physical and chemical instability observed up to one month of storage. Further development on herbal soft capsule can be continued. Design and manufacture of small-scale encapsulation machine was conducted to test the suitability of film formulation. The design ensures temperature of polymer was controlled to make the mass in liquid form; speed of drum casting maintained low and sincronized on critical encapsulation steps was done. The critical encapsulation steps are film casting using low speed drum casting; moulding of capsule shell in die roll mould; filling of the medicine; sealing and cutting of moulded soft capsule. Temperature control for polymer mass was made by double jacket tank equipped with internal heater. The low speed drum casting controlled using worm gear transmition system. Sincronize of critical encapsulation steps was conducted using microcontroller of Adruino. The small-scale encapsulation machine gives advantage to support efficient trial for product development and feasible for small-scale production.