DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS® AND LACTOSE USING THE DIRECT PRESS METHOD

Abstract

Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the ambroxol acceleration ambroxol in the body.
 Methods: Ambroxol HCl tablets were made by direct pressing method. For research purposes, 4 formulas with variations of Ludipress® and Lactose were designed. The tablet was then evaluated, which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups were used.
 Results: From the results of the Mass Printing Evaluation of Tablets, it was found that the four formulas that were designed met the resting angle, flow rate, real density, compressed density, and compressibility met existing requirements. The results of evaluation tablets, which included uniformity of weight, uniformity of size, hardness, friability, disintegration time, and dissolution test, were found that only F1 formula did not meet uniformity requirements. All four formulas meet the Indonesian pharmacopeia requirements for time of violence, fragility and disintegration. The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293 suggesting only the F3 formula fulfilled the dissolution requirements according to European Pharmacopoeia which stated that the concentration of dissolved active tablets should not be less than 75% during the 45-minute test.
 Conclusion: The formula that met the solubility requirements consisted of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%.

Thermo-Analytical and Compatibility Study with Mechanistic Explanation of Degradation Kinetics of Ambroxol Hydrochloride Tablets under Non-Isothermal Conditions

“…Such findings could be potentially attributed to the previous moisture effect. In addition, it should be noted that lactose monohydrate, one of the excipients in FT formulation, also interacts with moisture-sensitive drugs and affect the stability of the drug [27,44]. Koivisto et al [45] reported that Mg stearate (excipient as well) properties strongly depend on the moisture content and its hydration state [21].…”

“…stability of the drug [27,44]. Koivisto et al [45] reported that Mg stearate (excipient as well) properties strongly depend on the moisture content and its hydration state [21].…”

“…Furthermore, in this paper, special attention was given to the role of presented excipients for the stability determination of the dosage form and the evaluation of shelf-life values to prepare the ideal optimization procedure for the storage of pharmaceutical preparations [26,27]. It should be noted that the small pharmaceutical molecules and their reactions in the solid state have attracted the attention of scientists.…”

Development, Evaluation and in vitro Release Kinetics Study of Immediate Release Tablets of Quercetin Isolated from Bauhinia acuminata Leaves Extract

“…The amount of MCC in different formulations was 182.5, 177.5 and 172.5 mg/tablet respectively in F1, F2 and F3; whereas 10, 15 and 20 mg/tablet of sodium starch glycolate was used in F1, F2 and F3 respectively. The total weight of the single tablet was 250 mg. Next isolated quercetin was blended with diluents and then sodium starch glycolate were added, blended and the mixture thus obtained was ready for direct compression and compressed in tablet punching machine (8,9) . https://www.indjst.org/…”

“…USP dissolution test apparatus (paddle type, Lab India DS 8000) was employed containing 900 ml of phosphate buffer pH 7.4 at 37±0.5 0 C temperature and at 50 rpm for one hour. At every 10 minutes interval specified quantity of sample was withdrawn and further studied by UV Spectrophotometer at 369 nm (7,9) .…”