The preparation process of solid preparations mainly includes the following steps:
Preparation of raw and auxiliary materials: Firstly, weigh the raw and auxiliary materials according to the product production prescription and instructions, verify the product name, batch number, specifications, inspection and release status, and external packaging of the raw and auxiliary materials. This step is the foundation for ensuring product quality.
Crushing and sieving: Crushing drugs to reduce the particle size of the material, effectively increase the specific surface area, and improve the dissolution and bioavailability of insoluble drugs. The purpose of sieving is to obtain relatively uniform materials, improve the mixing uniformity of various components, and ensure the fluidity of particles.
Mixing: Mixing the crushed raw materials evenly is the main unit operation to ensure the uniformity of drug content. The quality of mixing is influenced by multiple factors such as the order, time, and frequency of mixing, and almost runs through the entire category of solid dosage forms.
Granulation: includes two processes: making soft materials and making wet particles. Mix the fine powder of the raw materials weighed according to the prescription, add an appropriate amount of wetting agent or adhesive, and mix well to form the soft material. Then, let the soft material pass through the sieve to form particles. The purpose of granulation includes improving fluidity, preventing segregation of various components, preventing dust from flying and adhesion on the vessel wall, etc.
Drying and granulation: Wet particles obtained through sieving should be immediately dried to prevent clumping or compression deformation. After drying, the particles need to be sieved and crushed to meet the particle size requirements of the granules or tablet compression requirements.
Tablet pressing and coating: The prepared particles are compressed into shape and can be prepared into tablets. For certain tablets, coating may also be necessary to improve their appearance, stability, or enhance patient compliance.
Quality inspection and packaging: Conduct quality inspection on the solid formulation to ensure that the product meets the predetermined standards before packaging and preparing for market launch.
This series of steps ensures the quality, safety, and effectiveness of solid formulations, while also taking into account production costs and efficiency.