Abstract
This research work presents the use of the Quality by Design (QbD) concept for optimization of the spherical agglomeration crystallization method in the case of the active agent, ambroxol hydrochloride (AMB HCl). AMB HCl spherical crystals were formulated by the spherical agglomeration method, which was applied as an antisolvent technique. Spherical crystals have good flowing properties, which makes the direct compression tableting method applicable. This means that the amount of additives used can be reduced and smaller tablets can be formed. For the risk assessment, LeanQbD Software was used. According to its results, four independent variables (mixing type and time, dT (temperature difference between solvent and antisolvent), and composition (solvent/antisolvent volume ratio)) and three dependent variables (mean particle size, aspect ratio, and roundness) were selected. Based on these, a 2–3 mixed-level factorial design was constructed, crystallization was accomplished, and the results were evaluated using Statistica for Windows 13 program. Product assay was performed and it was revealed that improvements in the mean particle size (from ~13 to ~200 µm), roundness (from ~2.4 to ~1.5), aspect ratio (from ~1.7 to ~1.4), and flow properties were observed while polymorphic transitions were avoided.
Highlights
The last step in the production of solid-form active agents and additives is generally crystallization.With the help of crystallization methods, can purification be achieved but the ideal crystal habit and polymorphic form can be produced
Direct compression improves the economic aspects by reducing the technological process steps
It is suitable for processing active substances into solid dosage forms, which is not applicable in the case of wet granulation
Summary
The last step in the production of solid-form active agents and additives is generally crystallization.With the help of crystallization methods, can purification be achieved but the ideal crystal habit and polymorphic form can be produced. The last step in the production of solid-form active agents and additives is generally crystallization. With the application of spherical crystallization methods, the flowability and the compressibility properties of the solid materials can be improved [1]. The appropriate particle size and powder rheological properties make the material suitable for direct tablet compression [2,3,4]. Direct compression improves the economic aspects by reducing the technological process steps It is suitable for processing active substances into solid dosage forms, which is not applicable in the case of wet granulation. If the active agent possesses an ideal habit, the amount of the used additives can be reduced In this way, the production of smaller tablets can be accomplished, which can help patients with dysphagia
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