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Pharmaceuticals Coating Solution for Film Coated Tablet: PROS and CONS
Greetings from Bio-Xin. BIO-XIN Introducing Breakthrough Technology for manufacturing tablet coating solution in Pharmaceuticals Industry of Bangladesh. Bio-Xin would like to propose you process which can help you to manufacture highest quality coating solution. Before proposing process I would like to explain some words on coating Pros and Cons. You are kindly requested to review below literature:
Reason for Tablet Coating:
Hydro-alcohol solvent systems are extensively used in the pharmaceutical field to apply functional and/or nonfunctional coating of tablets. Good product performance, including uniformity of coating and drug release, is a strong function of these coatings. Uniformity of tablet coating is extremely important as it affects the organoleptic quality of tablets and functionality of the coating, especially for modified release formulations1,2. The texture of coated membranes can affect drug release and lag time, which are important parameters in modified-release oral dosage forms1-3.
Component of Coating Solution:
Coatings generally consist of a sugar or cellulose based binder, plasticizer, film forming agent and colorant.These are supplied in granulated or powder form for dispersion in aqueous or organic solvents at concentration varying from 10 -20% depending on the desired properties and formula.
Important Factor for Coating Solution Manufacturing:
- Particle Size reduction
Traditional Coating Solution Manufacturing Process:
A typical method of dispersion is as follows:
- The water/solvent is charged into the mixing vessel, with the mixer positioned off center to create a vortex.
- The dry ingredients are added and drawn into the vortex.
- Mixing continues until the ingredients are fully dissolved.
- The finished coating is applied to the tablets by spraying in coating pans.
Factor Need to Consider:
In order to achieve the above, a number of processing factors must be considered:
- The mixer must be capable of circulating the entire contents of the vessel to ensure uniformity.
- A wide range of colors are used in tablet coatings, and batch sizes are generally small.
- Equipment must be easily cleaned and ideally adapted to be cleaned in place (CIP).
- The mixer must be capable of processing at ambient temperatures as some ingredients may be heat sensitive.
Problem of Traditional Mixing Technology
Whilst many proprietary coatings are designed to be easily dispersed, a number of problems are frequently encountered when using conventional mixers and agitators:
- Conventional agitators cannot rapidly dissolve materials at ambient temperatures.
- Agitators are not capable of rapidly breaking down agglomerates.
- A low particle size is required in order to avoid clogging of the spraying apparatus.
- If the colorant is not properly dispersed, flecks of color can occur in the tablets.
Bio-Xin’s Solution for Tablet Coating:
Bio-Xin is providing solution with IKA high shear inline Homogenizer which can overcome all of these manufacturing difficulties. The rotor/stator workhead is capable of dissolving sugar and dispersing cellulose type materials in a fraction of the time taken by conventional agitators, operating as follows:
The Vessel is charged with the base liquid. The mixer (IKA Agitator) is started and the coating granules and other ingredients are added. The rotations of the Agitator confirm premixing. An efficient generator (rotor-stator system) in the inline Homogenizer in the bottom of the vessel produces very high shear forces and thus dispersions with long-term stability and ultra-fine droplets.
- Because of the high rotor speed, the medium (granulated or powdered coating material and liquid) to be processed is automatically sucked axially into the dispersing head and is then driven radially through the slots of the rotor-stator arrangement.
- Due to the great force of acceleration, the material is subjected to very high shearing and thrusting forces, causing the reduction of the particle size.
- The additional high turbulence occurring in the shearing gap between the rotor and the stator leads to an intensive mixing of the material.
- Rotor rotates on shaft axis enclosed in stator
- Fluid enters on the same axis as drive shaft
- Momentum is changed 90 degrees and moves in radial direction due to centrifugal force
- Fluid enters channel between rotor teeth subjected to centrifugal thrust
Advantages of the System:
- Consistent product quality and repeatability.
- Agglomerate-free mix.
- Rapid mixing time.
- Maximized yield of raw materials as thickening agents are fully hydrated and other ingredients fully dispersed.
- Bhagwant DR, John G, Jim HK. Identification of critical process variables for coating actives onto tablets via statistically designed experiments. Int J Pharm, 2002; 237: 87–94.
- Elaine SKT, Celine VL, Dawn ZL, Xiaohua L, Anthony JW, Paul WSH. Study of coat quality of tablets coated by an on-line supercell coater. AAPS PharmSciTech, 2007; 8: E1-E7
- Mikko J, Bert VV, Kai-Erik P, Jarkko K, Valtteri K, Raimo S, Tuula TP. Local and average gloss from flat-faced sodium chloride tablets. AAPS PharmSciTech, 2006; 7: E1-E6.