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Large scale manufacture of suspension emulsion sb

The document discusses biphasic systems and the large-scale manufacture of emulsions and suspensions. It describes various equipment used such as ball mills, fluid energy mills, cutter mills, hammer mills, end runner mills, and colloidal mills. It focuses on the colloidal mill, explaining that it uses shear force to reduce particle size in suspensions and emulsions. The colloidal mill consists of a rotor and stator that grind material passing between them, reducing particles down to 1 micron. It is commonly used in pharmaceutical applications to produce stable suspensions, emulsions, and ointments.

Engineering◦
Biphasic Systems (Large scale manufacture of emulsions & suspensions) Mr. Mirza Salman Baig Assistant Professor (Pharmaceutics) AIKTC, School of Pharmacy, New Panvel Affiliated to University of Mumbai (INDIA)
Large scale manufacture of emulsions & suspensions Layout Equipments Collidal mill QC for suspension /emulsion
Equipments for Suspension • Ball mill • Fluid energy mill • Cutter mill • Hammer mill • End runner mill • Collidal mill
QC Suspension • Sedimentation volume (Hu/H0) • Rheological test (Brookfield) • Electrokinetic test (Electrophoresis) • Zeta potential • Particle Size distrubution • Photo microscopy (Coulter counter) • Sp Gravity • Drug content uniformity (assay) • Redispersibility (simulated human arm shaker)
Equipments for emulsion • Agitators • Mechanical mixers • Collidal mill • Homogenizer • Ultrasonic Devices
QC Suspension/emulsion Stress conditions • Ageing and Temperature (40-450C) • Centrifugation (3500 rpm) • Agitation Physical Parameters • Phase Seperation • Viscosity
General Layout
Colloidal mill • The colloidal mill is used in the reduction of the particles or solid materials which are present in the suspensions or emulsion. • The shearing is the mechanism in the colloidal mill. • By the stator and the rotor present in the cylindrical vessel of the colloidal mill the shearing take place and the reduction of the particles takes place
Basic parts • It consists of an inlet hopper which is used to feed the material into the mill. • It consists of a rotor and stator which are used to reduce the particles size by applying the shearing force. • It consists of an outlet which is used to discharge the reduced particles.
Construction • A colloidal mill consist of a high speed rotor and a stator with a conical milling surfaces between • Which is an adjustable clearance ranging from 0.002 to 0.03 inches. • The rotor speed is 3000 to 20,000rpm. • The material to be ground should be pre milled as finely as possible to prevent damage to the colloidal mill. • Rotors and the stator may be smooth surfaced or rough surface. With the rotor and the stator there is a thin uniform film of material between them and it is subjected to the maximum amount of shear. • Rough surfaced mill add intense eddy current, turbulence and the impaction of the particles to the shearing action
Principle • Colloidal mill works on the principle of rotor- stator. • The size reduction is affected due to shearing, when the material is passed between the narrow gap of milling surfaces of rotor and stator. • The high levels of hydraulic shear applied to the process liquid disrupt structures in the fluid. • Higher shear rates leads to smaller droplets of 1 micron. • Based on a rotor rotating at high speed and very close to a conical stator, the particle size is done by modifying the gap between the rotor and the stator.
Working • The material is placed into the mill though the inlet hopper. • It is then passed through the narrow gap between the rotor and stator and thus reduced the fine particle size. • A colloid mill is a hydraulic shear producing device. A rotor turns at high speeds of 3000 - 20000rpm • The colloid mill works to reduce the size of the suspended droplets. • The mill allows the solid particles to become so small.
Collidal mill
Colloidal mill The main use of a colloid mill is the dispersion of solid particles within a liquid. • It is used to reduce the particle size in suspension in a liquid or to reduce the droplet size of a liquid suspended in another liquid. • By applying high levels of hydraulic shear to the process liquid the reduction is done. • It is frequently used to increase the stability of suspensions and emulsions. • It is used for the formation of the efficient emulsification, homogenization, dispersion and mixing during the course of cutting, milling and shocking with high frequency. • Colloidal mill is utilized in a number of industries including, food and beverage, pharmaceuticals and chemicals. • Colloidal mill is ideal for small, medium and large scale tablet batching systems. The colloid mill is the most efficient system for dispersion and homogenization of raw material. • It is mainly used in pharmaceutical purpose for the preparations colloidal dispersions, suspensions, emulsions and ointments. • Particles size of as small as 3 microns can be obtained by the colloidal mill. • Fibrous materials can be milled using rough surfaced rotor and stator. • Colloidal mill can be sterilized hence, it can be mainly used in the production of the sterile products.
Filling and packaging of pharmaceutical suspension • The common packaging presentations for commercial oral liquid pediatric drug products are glass bottle, plastic bottle, sachet, and stick pack configurations. • Oral liquid pediatric formulations are typically prepared from a powder that is constituted at the time of use as a suspension or a solution for single or multiple use depending on the stability of the constituted formulation • Active ingredients with low aqueous solubility can be developed as a powder for oral suspension and presented in a bottle for multiple use product and a stick pack or sachet for single‐use product. • A secondary package may be used in cases where the primary pack failed to provide adequate protection against light degradation.