Validation of solid dosage forms

Views:
 
Category: Education
     
 

Presentation Description

validation procedure for solid dosage forms, validation of raw materials, validation of excipients. various stages involved in the process validation of tablet dosage forms

Comments

Presentation Transcript

PowerPoint Presentation:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system QIS COLLEGE OF PHARMACY ONGOLE, andhra pradesh COURSE MATERIAL Topic : VALIDATION OF SOLID DOSAGE FORMS Subject : Dosage Form Design & Novel Drug delivery system Course : IV B.Pharmacy, II Semester Prepared By : Mr. S. CHELLARAM

PRODUCT VALIDATION:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system PRODUCT VALIDATION Product validation is associated with validation of the full-scale manufacture of pharmaceutical processes as well as validation of numerous earlier aspects of product development that are critical to the subsequent phases of the process. Without proper characterization, specification, and control of these earlier development steps, the foundation will be weak and will not support the evolving product when it is challenged during the formal validation of pilot and production batches. Product validation involves following steps: I. VALIDATION OF RAW MATERIALS & EXCIPIENTS II. ANALYTICAL METHODS VALIDATION III. EQUIPMENT & FACILITY VALIDATION IV. PROCESS VARIABLES AND LIMITS

I. VALIDATION OF RAW MATERIALS & EXCIPIENTS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system I. VALIDATION OF RAW MATERIALS & EXCIPIENTS Variation in raw materials is one of the major causes of product variation or deviation from specification. The API may represent the most uncontrollable component in the complete product/process validation scheme, as key physical properties such as morphology and particle size/surface area may not be uniform. The validation process of a solid dosage form begins with a validation of the raw materials, both active pharmaceutical ingredients (APIs) and excipients. Preformulation is one of the critical steps to be validated in the product validation. Physical characteristics such as drug morphology, solubility, and particle size/ surface area can affect material flow and blend uniformity . Chemical characteristics such as impurities and impurity levels can affect the stability of the drug in the formulation. The hygroscopic nature of the drug can be important in both the handling the material and the reproducibility of the manufacturing process.

VALIDATION OF RAW MATERIALS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system VALIDATION OF RAW MATERIALS Water-insoluble drug is usually milled or micronized to increase dissolution and in vitro drug release . Large surface area is created due to decrease in particle size which may cause problems in flow, blend uniformity, granulation solution/binder uptake . If the milling or micronizing process is not controlled and properly validated then irregularities in blend distribution will result in content uniformity problems of the final dosage form . Another characteristic is the volume of granulating solution or binder needed to produce a properly agglomerated mass. Large volume of granulating agent will be needed for finely divided particles than for coarser particles of the same substance. If the particle size/surface area ratio is not controlled and a specific amount of granulating solution is not stated in the product manufacturing directions, then in some cases the wet mass will be overwet, resulting in erratic drying properties (case-hardening, insufficient dried product), or in contrast, it will be too dry and will not form proper granules, resulting in poor granulation flow, poor tablet compressibility, and content uniformity problems with the final dosage form.

VALIDATION OF EXCIPIENTS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Excipients can represent less than 1% of a tablet formula or as much as 99%. Factors to be aware of are (1) the grade and source of the excipients, (2) particle size and shape characteristics, and (3) lot-to-lot variability. Microcrystalline cellulose (MCC) used as a diluent shows significant differences in the chemical composition, crystallinity, and particle size/size distribution between different lots. Differences in the particle size/size distribution of microcrystalline cellulose can affect the wet granulation step and/or blend uniformity of a tablet formulation. In direct compression formulations, differences in particle size distribution between lots can result in (1) Non uniformity in initial mix. (2) materials segregating during compression. Smaller particles will require increased binder solution to granulate and could result in granules having greater strength, decreasing dissolution. VALIDATION OF EXCIPIENTS

VALIDATION OF EXCIPIENTS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Magnesium stearate used as a lubricant to reduce friction during compression. Action of mag.stearate is highly dependent on its particle size. Excess of mag.stearate produces hydrophobic coating causing differences in the disintegration and dissolution characteristics of the final tablet or capsule. This hydrophobic coating action can also be developed by using a smaller particle size or greater surface area lubricant. It is critical to validate the particle size/surface area characteristics of a supplier’s grade of magnesium stearate to ensure that there is relatively good assurance that the stearate is uniform lot after lot. Also, when an alternate source of stearate is sought, it is critical to check the particle size/surface area and shape characteristics to ensure that these parameters do not vary significantly from the primary source material. Dissolution testing would also be conducted as a companion test, again to ensure that the new stearate did not create in vitro drug release problems. VALIDATION OF EXCIPIENTS

VALIDATION OF EXCIPIENTS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system The importance of validating a excipients can also be illustrated in the case of dyes used to impart a color to a tablet. Aluminium lake dye is dry-blended into a direct compression tablet formulation. In order to achieve an even color distribution, the colorant should be added using a geometric addition or preblend approach. The dye should be finely divided, having large surface area and free from agglomerates. If there is variation then the resulting tablets will be mottled and have areas of high dye concentration, which may yield a speckled tablet appearance. The validation of colorant raw materials using such techniques as particle size analysis, surface area measurements is critical to ensure that all lots of dye material received will repeatedly perform in a successful manner when incorporated into pharmaceutical dosage forms. VALIDATION OF EXCIPIENTS

STEPS IN DOING VALIDATION OF RAW MATERIALS :

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system STEPS IN DOING VALIDATION OF RAW MATERIALS As per cGMP the steps involved in the validation of a raw material or excipient are Each raw material should be validated by performing checks on at least 3 batches from the primary supplier as well as the alternate supplier. The batches chosen should be selected to represent the range of acceptable specifications, both high and low. Physical, chemical, and/or microbiological stability should be assessed. This is applicable for liquid or semisolid ingredients, in which interaction with the container or permeability of the container to air and moisture could have a detrimental effect on the raw material. Several lots of final product are produced with samples raw material at the low and high ends of the specification limit. On-site inspection of the supplier to review the vendor’s manufacturing operations and control procedures.

II. ANALYTICAL METHODS VALIDATION:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system II. ANALYTICAL METHODS VALIDATION 1. Accuracy of method: ability of a method to measure the true value of a sample. 2. Precision of method: ability of a method to estimate reproducibility of any given value. 3. Specificity: ability to accurately measure the analyte in the presence of other components. 4. Repeatability: Does the precision and accuracy of the method change when conducted numerous times on the same day and repeated on a subsequent day? 5. Reproducibility : Repeat of the precision and accuracy studies within the same laboratory using the same instrument but different analysts to challenge the reproducibility of the method. 6. Intermediate precision: How will different instruments within the same laboratory run by the same analyst affect the accuracy and precision of the method? 7. Ruggedness: Will the precision and accuracy of the method be the same between the development and quality control laboratories?

II. ANALYTICAL METHODS VALIDATION:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system A collaborative study between chemists of ARD who developed the analytical method and the analytical chemists in the QC who must routinely run the method will help to ensure the validity and ruggedness of the analytical method. If characteristics of the analytical method are found to be less the method should be returned for re-evaluation. QC require a robust method that can be run by different chemists on different instruments in some cases, the method should be automated. It is the responsibility of the analytical methods development chemist to build these important elements into the methods. Responsibility of QC management to ensure that its staff is adequately trained and its laboratories properly equipped so that new analytical methods can be properly transferred from ARD to QC. Outsourcing the development, validation, and performance of analytical methods in recent years has become a popular means to facilitate movement of product through the development process. II. ANALYTICAL METHODS VALIDATION

III. EQUIPMENT VALIDATION :

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system III. EQUIPMENT VALIDATION Process equipment used in the development phase is assessed relative to its suitability for large-scale manufacture . Alternate equipment is identified and evaluated and a final decision rendered. Existing or new equipment to be used to manufacture the new pharmaceutical product must then undergo a comprehensive evaluation called a validation protocol. This protocol can be divided into a number of components, but usually has Design qualification Installation qualification Operation qualification Performance qualification Maintenance (calibration, cleaning, and repair) qualification

IV. PROCESS VARIABLES AND LIMITS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system IV. PROCESS VARIABLES AND LIMITS Process validation can be defined as a means of challenging a process during development to determine which variables must be controlled to ensure the consistent production of a product or intermediate. It is based on the concept that the process employed has been optimized, so that data generated through the testing program may be considered credible and evaluated for consistency as well as relevance. The activity starts when the pharmaceutical development department begins its work. Pertinent data or information are collected during the preformulation stage , and additional inputs are generated during formulation development and evaluation, process development , and full-scale manufacture . The information gathered in all four stages is evaluated to determine which parameters in the process can be used as possible tools to show that the product is under proper control.

IV. PROCESS VARIABLES AND LIMITS:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 1. Obtaining test data to determine the numerical range of each parameter e.g., assess the tablet hardness over a series of batches that achieves an acceptable friability, disintegration, and dissolution. 2. Establishing specification limits from the test data derived for a given parameter. Based on the data collected and using statistical techniques, determine the extremes of acceptable hardness (high and low) that would provide 95% assurance that the friability, disintegration, and dissolution specifications would be met (upper and lower control/ release limits). 3. Determining how well the specification limit indicates that the process is under control. Challenge the process by producing product at the extremes of the specification limit to ensure all product specifications are met. 4. Certifying the equipment that is used in obtaining the data and controlling the process.Ensure that equipment operating conditions (e.g., rpm, temperature, power utilization) are within specification limits under variations of product load. IV. PROCESS VARIABLES AND LIMITS

VALIDATION OF TABLET DOSAGE FORM:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system VALIDATION OF TABLET DOSAGE FORM A. TABLET COMPOSITION Identification of the key physicochemical properties of the drug substance that need to be considered in developing the formulation, such as Solubility of the drug throughout the physiological pH range: Depending on the solubility of the drug, a surfactant may be needed to enhance dissolution. Particle size distribution and surface area: determines what grade of an excipient (e.g., MCC) to use. Morphology: If the drug is polymorphs, certain excipients may be used to prevent conversion of the drug to other physical forms. True and bulk density: An excipient (e.g., diluent) that has a similar bulk density as the drug may be selected to minimize segregation, especially with a direct compression formulation.

TABLET COMPOSITION:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Material flow and compressibility : A free flowing, highly compressible material such as MCC may be used for drugs with poor flow or compressibility properties. Hygroscopicity: Special environmental working conditions may be required to ensure that moisture is not picked up during material storage or handling and during the manufacture of the tablet dosage form. Melting point : If the drug has a low melting point, a direct compression formulation may need to be developed instead of a wet granulation formulation to avoid drying the material and potentially melting or degrading the drug TABLET COMPOSITION

1. Mixing or Blending:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 1. Mixing or Blending The mixing or blending unit operation may occur once or several times during the tablet manufacture. Direct compression formulation may involve 1 blending step in which the drug and the excipients are blended together prior to compression . A wet granulation formulation may require 2 mixing/blending steps: (1) prior to granulating to have a uniform drug/excipients mixture, and (2) dried granules are added with other excipients , such as the lubricant. The Physical properties of the drug and excipients creating a uniform mix or blend are Bulk density Particle shape Particle size distribution Surface area Materials that have similar physical properties will be easier to form a uniform mix or blend and will not segregate as readily.

1. Mixing or Blending:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Mixing or blending technique: Diffusion (tumble), convection (planetary or high intensity), or pneumatic (fluid bed) techniques can be used to mix or blend materials. Selection of technique depends upon whether mixing the drug and excipients for a direct compression formulation or adding the lubricant (e.g., magnesium stearate) to the granulation. Mixing or blending speed: Determine the intensity (low/high shear) and/or speed (rpm) of the mixing or blending. Mixing the drug and excipient will require more intense mixing than adding the lubricant to the final blend. Mixing or blending time: The mixing or blending time will be dependent on the mixing or blending technique and speed. Experiments should be done to determine if the materials are overmixed, resulting in demixing or segregation of the materials. Demixing can occur due to the physical property differences (e.g., particle size distribution and density). If drug substance is micronized (5 microns) and the excipients are granular (500–1000 microns). 1. Mixing or Blending

1. Mixing or Blending:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Drug uniformity: Content uniformity is usually performed to determine the uniformity of drug throughout the mix or blend. Representative samples should be taken throughout the mix or blend. The sampling technique and handling of the materials are key in obtaining valid content uniformity results. Segregation of the sample can occur by overhandling, resulting in inaccurate results. For the final blend (blend prior to compression), the sample taken should be equivalent to the weight of a single tablet. Excipient uniformity: 2 key excipients are: Lubricant: The lubricant needs to be distributed uniformly in the mixture/granulation for the high-speed compression operation. Uneven distribution of the lubricant can result in picking and sticky problems during compression. It can also lead to tablet performance problems (low dissolution due to excessive lubricant in some tablets). Color: The colorant(s) need(s) to be evenly distributed in the mixture so that the tablets have a uniform appearance (e.g., color, hue, and intensity). The coloring agent may need to be prescreened or more uniformally dispersed in the blend prior to compression to avoid speckling or shading of the color. 1. Mixing or Blending

PowerPoint Presentation:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Equipment capacity/load : The bulk density of materials or granules will affect the capacity of the equipment. If an excipient in the formulation affects the density of the final blend to a greater extent than any other ingredient, then a well-controlled density specification for that excipient may be warranted. Test different-sized loads in the mixer/ blender (e.g., 30, 50, and 70% of working volume) for optimal mixing or blending. Undercharging or overcharging a blender can result in poor drug or tablet lubricant distribution.

2. Wet Granulation:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 2. Wet Granulation Wet granulation technique: low shear (e.g., Hobart), high shear (e.g., Diosna, GEI-Collette) or fluid bed (e.g., Glatt, Fluid Air) Each technique will produce granules with different physical properties and will require monitoring of different processing parameters. Binder addition: Binder can be added as a granulating solution or dry like the other excipients. Adding the binder dry avoids the need to determine the optimal binder concentration and a separate manufacture for the binder solution . Binder concentration: The optimal binder concentration will need to be determined for the formulation. If the binder is to be sprayed , the binder solution needs to be dilute enough so that it can be pumped through the spray nozzle. It should also be sufficiently concentrated to form granules without over wetting. Amount of binder solution/granulating solvent: Too much binder or solvent solution will overwet the materials and prolong the drying time. The amount of binder solution is related to the binder concentration.

2. Wet Granulation:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Binder solution/granulating solvent addition rate: Granulating solution can be dumped into the mixer or it can be metered in at a specific rate. If metered then , rate or rate range at which the binder solution or granulating solvent to be added to the materials should be determined. Mixing time: Time required for the formation of granules to be deteremined. Granulations that are not mixed long enough can form incomplete or weak granules . These granules may have poor flow and compression properties . On the other hand, overmixing the granulation can lead to harder granules and a lower dissolution rate . Granulation end point: Granulation end point can be determined and controlled by granulation end point equipment namely ammeter or 2. Wet Granulation

3. Wet Milling:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 3. Wet Milling In some cases wet granulation need to be milled to break up the lumps and enhance drying of the granulation. Factors to consider are: Equipment size and capacity: The mill should be large enough to delump the entire batch within a reasonable time period to minimize manufacturing time and prevent the material from drying during this operation. Screen size: The screen needs to be small enough to delump the material, but not too small to cause excessive heating of the mill, resulting in drying of the granulation. Mill speed: The speed should be sufficient to efficiently delump the material without straining the equipment. Feed rate: The feed rate of the wet granulation is interrelated to screen size and mill size and speed.

4. Drying:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 4. Drying The type of drying technique namely tray, fluid bed, microwave required for the formulation needs to be determined and justified. The type of technique dependent formulation properties and equipment availability & could affect tablet hardness, disinteg. dissoln, and stability. Under dried granules with high moisture content can result in (1) tablet picking or sticking to tablet punch surfaces and (2) poor chemical stability as a result of hydrolysis. An overdried granulation could result in poor hardness and friability . Moisture content analysis can be performed using the conventional loss-on-drying techniques or such state-of-the-art techniques as near infrared (NIR) spectroscopy

4. Drying:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 4. Drying Inlet/outlet temperature: The inlet temperature is the temperature of the incoming air to the dryer, while the outlet temperature is the temperature leaving the unit. The inlet temperature is critical to the drying efficiency of the granulation and should be set high enough to maximize drying without affecting the chemical/physical stability of the granulation. The outlet temperature is an indicator of the granulation temperature and will increase toward the inlet temperature as the moisture content of the granulation decreases (evaporization rate). Airflow: There should be sufficient airflow to ensure removal of moisture laden air from the wet granulation. Insufficient airflow could prolong drying and affect the chemical stability of the drug. Airflow and the inlet/outlet temperature are interrelated parameters and should be considered together.

4. Drying:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 4. Drying Moisture uniformity: The moisture content could vary within the granulation. Heat uniformity of the dryer (e.g., tray), amount of granulation per tray , and incomplete fluidization of the bed are factors that could affect the moisture uniformity of the granulation. Equipment capability/capacity: The load that can be efficiently dried within the unit needs to be known. A larger load will require more moisture to be removed on drying and will affect the drying time. In the case of fluid bed drying, a maximum dryer load is that load above which the dryer will not fluidize the material

5. Milling :

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 5. Milling The milling operation will reduce the particle size of the dried granulation. The resultant particle size distribution will affect such material properties as flow, compressibility, disintegration, and dissolution . An optimal particle size/size distribution for the formulation will need to be determined Mill type: Type of mill type are impact or screen . Particle size distribution depends upon type of mill used. Particle size testing will need to be conducted and the results examined when substituting mill types. Screen size: A smaller screen size will produce a smaller particle size and a greater number of fines. Mill speed: A higher mill speed will result in a smaller particle size and possibly a wider particle size distribution . It also generate more heat to the product, depending on the screen size and feed rate, which could affect the stability of the product Feed rate: The feed rate is dependent on the mill capacity, screen size, and mill speed .

6. Tablet Compression:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 6. Tablet Compression Compression is a critical step in the production of a tablet dosage form. The materials being compressed will need to have adequate flow and compression properties . The material should readily flow from the hopper onto the feed frame and into the dies. Inadequate flow can result in “ rat holing ” in the hopper and/ or segregation of the blend in the hopper/feed frame. This can cause tablet weight and content uniformity problems . Tooling: The shape, size, and concavity of the tooling should be based on the formulation properties and commercial specifications. For intagliated (embossed) tablets, factors such as the position of the intagliation on the tablet and the intagliation depth and style should be examined to ensure that picking of the intagliation during compression or fill-in of the intagliation during coating does not occur. Compression speed: The formulation should be compressed at a wide range of compression speeds to determine the operating range of the compressor. The adequacy of the material’s flow into the dies will be determined by examining the tablet weights.

6. Tablet Compression:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Compression/ejection force: The compression profile need to be determined to establish the optimal compression force to obtain the desired tablet hardness. The particle size/size distribution or level of lubricant may need to be adjusted in order to have a robust process on a high-speed compressor. The following in-process tests should be done during compression stage: Appearance Hardness Tablet weight Friability Disintegration Weight uniformity 6. Tablet Compression

7. Tablet Coating:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system 7. Tablet Coating Tablets may be coated for various reasons. Stability,Taste masking, Controlled release,Product identification Aesthetics and Safety–material handling Different techniques are sugar, film, or compression. Tablet properties: Hardness, shape, and intagliation are important to obtain a good film-coated tablet . The tablet should be hard to withstand the coating process. If tablet attrition occurs, the tablets will have a rough surface appearance. A round tablet will be easier to coat than tablets will multiple sides or edges because of the uniformity of the surface. For intagliated tablets, the intagliation style and depth should be developed to prevent fill-in or chipping of the intagliation. Equipment type: Conventional or perforated pan and fluid bed coaters are potential options.

7. Tablet Coating:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Coater load: Too large a pan load could cause attrition of the tablets because of the overall tablet weight in the coater. In the case of a fluid bed coater , there may not be sufficient airflow to fluidize the tablets. Pan speed: Pan speed is interrelated to other coating parameters, such as inlet temperature, spray rate, and flow rate. Spray guns: The number and types of guns should be determined in order to efficiently coat the tablets. The spray nozzles should be sized properly to ensure even distribution over the tablet bed and to prevent clogging of the nozzles. The location and angle of the spray gun(s) should be positioned to get adequate coverage. Having the guns positioned too close together can lead to a portion of the tablets to be overwet. 7. Tablet Coating

7. Tablet Coating:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Application/spray rate: Spraying too fast will cause the tablets to become overwet, resulting in clumping of tablets and possible dissolution of the tablet surface. Spraying too slowly will cause the coating materials to dry prior to adhesion to the tablets . causing a rough tablet surface and poor coating efficiency. Tablet flow: There should be sufficient tablet bed movement for even distribution of the coating solution onto the tablets. The addition of baffles may be required to provide adequate movement of tablets for tablet coating. Inlet/outlet temperature and airflow: These parameters are interrelated and should be set to ensure that the atomized coating solution reaches the tablet surface and then is quickly dried. Coating solution: The concentration and viscosity of the coating solution are important. The solution will need to be sufficiently diluted in order to spray the material on the tablets. The concentration of the coating solution will also determine the amount and volume of solution to be applied to the tablets. The stability of the coating solution should be investigated to establish its shelf life. 7. Tablet Coating

7. Tablet Coating:

Mr.S.Chellaram VALIDATION OF SOLID DOSAGE FORM Dosage form design & QISCP Novel drug delivery system Coating weight: A minimum and maximum coating weight should be established for the tablet. Sufficient coating material should be applied to the tablets to provide a uniform appearance. Residual solvent level: If solvents are used for tablet coating, the residual solvent level will need to be determined. Appearance testing of the tablets is critical during the coating operation. Quality control test for coating are: Cracking or peeling of the coating Intagliation fill-in Surface roughness Color uniformity 7. Tablet Coating

authorStream Live Help