Mixing in pharmaceutical engineering is a vital process that ensures the uniformity and stability of pharmaceutical formulations, whether they involve solids, liquids, or gases. This process typically includes various methods such as solid-solid mixing, which blends powders using equipment like V-bl...
Mixing in pharmaceutical engineering is a vital process that ensures the uniformity and stability of pharmaceutical formulations, whether they involve solids, liquids, or gases. This process typically includes various methods such as solid-solid mixing, which blends powders using equipment like V-blenders, and liquid-liquid mixing, often facilitated by high-shear mixers or homogenizers for creating emulsions and solutions. Key parameters such as mixing speed, time, and temperature are carefully controlled to achieve the desired product quality without degrading sensitive compounds. Quality control measures, including homogeneity testing and stability studies, are essential to validate the efficacy and safety of the final products. Compliance with Good Manufacturing Practices (GMP) and regulatory standards is crucial, particularly during scale-up from laboratory to production levels, where challenges related to efficiency and consistency may arise. Overall, effective mixing directly impacts the success of pharmaceutical products, making it a cornerstone of the industry.
Size: 51.17 KB
Language: en
Added: Sep 25, 2024
Slides: 18 pages
Slide Content
PHARMACEUTICAL ENGINEERING MIXING P. DAKSHINESH B. pharmacy (III sem )
DEFINITION MIXING is defined as a process that tends to result in a randomization of dissimilar particles within a system.
CONTENT Objectives Application Factors affecting
OBJECTIVES
SIMPLE PHYSICAL MIXTURE This may be simply the production of a blend of a blend of two or more miscible liquids or two or more uniformly divided solids. In pharmaceutical practice, the degree of mixing must commonly be of a high order, as many such mixture are dilutions of a potent substance, and correct dosage must be ensured.
PHYSICAL CHANGE Mixing may aim at producing a change that is physical as distinct from chemical, for example the solution of a soluble substance. In such cases, a lower efficiency of mixing will often be acceptable because the mixing merely accelerates a process that could occur by diffusion, without agitation.
DISPERSION This includes the dispersion of two immiscible liquids to form a emulsion or the dispersion of a solid in a liquid to give a suspension or paste. Usually good mixing is required to ensure stability.
PROMOTION OF REACTION Mixing will usually encourage (and control at same time) a chemical reaction, so ensure uniform products. Examples of this type include product or process where accurate adjustment to pH is required and the degree of mixing will depend on the process.
APPLICATION
Mixing is one of the most common pharmaceutical operations. Wet mixing in the granulation step in the production of tablets and capsules. Dry mixing of several ingredients ready for direct compression as in tablets. Dry blending of powders in capsules, dry syrups and compound powders (insufflations). Production of pellets for capsules.
FACTORS AFFECTING OF MIXING
NATURE OF THE SURFACE Rough surface of one of the components does not induce satisfactory mixing. This can be due to the entry of active substance into the pores of the other ingredients. Adding a substance, which will be absorbed on its surface, can decrease aggregation. Example is the addition of aerosil ( colloidal silicon dioxide ) to zinc oxide. Thus, strongly aggregation zinc oxide become a fine dusting powder, which can be mixed easily.
DENSITY OF THE PARTICLES Demixing is accelerated when the density of the smaller particles is higher or when the mixing process is stopped abruptly. This is due to the fact that dense material always moves downward and settles at the bottom.
PARTICLE SIZE As the particle size increases, flow properties also increases due to the influence of gravitational force on the size. Beyond a particular point, flow property decreases. The powders with a mean particle size of less than 100µm are free flowing, which facilitates mixing.
PARICLE SHAPE The ideal particle is spherical in shape for purpose of uniform mixing. The irregular shapes can become interlocked and are less chances of separation of particles once these are mixed together.
PARTICLE CHARGE Some particles exert attractive forces due to electrostatic charges on them. This can lead to separation or segregation.
PROPORTION OF MATERIALS The best results can be obtained if two powders are mixed in equal proportion by weight and by volume. If there is a large difference in the proportion of two powders, mixing is always done in the ascending order of their weights.