Specific application of dry granulation technology in the pharmaceutical industry
Dry granulation technology, as a solvent-free granulation method, is widely used in the pharmaceutical industry. Compared with wet granulation, dry granulation has the following advantages:
Avoid solvent residue: Since no solvent is used, the influence of solvent residue on product quality can be avoided, which is particularly suitable for drugs that are sensitive to solvents.
Easy to operate: The process flow is relatively simple and easy to operate.
Low energy consumption: No drying process is required, and energy consumption is low.
Applicable to heat-sensitive materials: Avoids the damage of heat-sensitive materials by high temperature.
Specific application scenarios of dry granulation technology in the pharmaceutical industry
Direct tableting:
High particle strength: The particles obtained by dry granulation have high strength and can be directly used for tableting without adding adhesives.
Applicable to difficult-to-compress materials: It can improve the fluidity and tableting performance of difficult-to-compress materials.
Improve tablet quality: The tablets obtained have fast disintegration time and high bioavailability.
Pre-treatment for coating:
Improve the fluidity of particles: Dry granulation can improve the fluidity of particles and facilitate the subsequent coating process.
Improve the coating effect: The coating layer and the core particles are more firmly bonded.
Preparing sustained-release preparations:
Controlling drug release: By adjusting the process parameters, the release rate of the drug can be controlled to prepare sustained-release preparations.
Types and characteristics of dry granulation technology
Roller granulation: The material is pressed into sheets or strips by applying pressure with a roller, and then broken into particles. It is suitable for materials with larger particle sizes, and the prepared particles have high strength.
Extrusion granulation: The material is extruded through the die hole to form strips or filaments, and then broken into particles. It is suitable for materials with good plasticity, and the prepared particles have regular shapes.
Fluidized bed granulation: The material is collided and rubbed on the fluidized bed to make the particles gradually grow. It is suitable for materials with smaller particle sizes, and the prepared particles have uniform particle size distribution.
Challenges and solutions of dry granulation technology in the pharmaceutical industry
Dust problem: A large amount of dust will be generated during the dry granulation process, and it is necessary to strengthen the sealing and dust removal measures.
Insufficient particle strength: The particle strength of some materials is not enough, and it is necessary to add additives or optimize process parameters.
Equipment wear: Long-term operation of the equipment will cause wear and tear, and regular maintenance and replacement of wearing parts are required.