Performance Metrics Development Approach

MANUFACTURING BASICSSolid Orals Tablets

- Jhony Sheik

Introduction:

Tablet is a pharmaceuticaldosage form.

It comprises a mixture of active Pharmaceutical Ingredients andexcipients.

It is pressed or compacted from a powder into a solid dose.

Advantages:Advantages afforded to the manufacturer 1- simplicity 2- economy of preparation3-stability 4-convenience in packaging, shipping and dispensing

Advantages to the patient 1-accuracy of dosage2-compactness3-portability4-blandness of taste 5-ease of administration.

Disadvantages:DisadvantagesThe manufacture of tablets requires a series of unit operations and therefore there is an increased level of product loss at each stage in the manufacturing process.The absorption of therapeutic agents from tablets is dependent on physiological factors, e.g. gastric emptying rate, and shows inter patient variation.The compression properties of certain therapeutic agents are poor and may present problems in their subsequent formulation and manufacture as tablets.The administration of tablets to certain groups, e.g. children and the elderly may be problematic due to difficulties in swallowing. These problems may be overcome by using effervescent tablet dosage forms.

Tablet Type:Tablet types available includeConventional compressed tabletsMultiple compressed tabletsEnteric-coated tabletsSugar-coated tabletsFilm-coated tablets Chewable tabletsEffervescent tabletsBuccal and sublingual tablets

APIFiller

Mixing of granulation blendGranulationBinder(s)Preparation of binder solutionDryingMillingLODDisintegrantscreeningscreeningInitial BlendinglubricantFinal BlendingCompressionSolventFilm coating agentPreparationFilm Coating of TabletsPackaging and LabellingWeightHardnessFriability

screeningFlow Chart:

Process Steps:

Dispensing

Milling/Screening

Granulation

Drying

Blending

Compression

Coating

Packaging

Dispensing:One of the most critical steps in pharmaceutical manufacturingmanual weighing on a weight scale with material lifting assistance like vacuum transfer and bag liftersautomated weighing

Milling / Screening:Principle: Mixing or blending is more uniform if ingredients are of similar sizeThe sizing (size reduction, milling, crushing, grinding, pulverization) is an important step (unit operation) involved in the tablet manufacturing. In manufacturing of compressed tablet, the mixing or blending of several solid ingredients of pharmaceuticals is easier and more uniform if the ingredients are approximately of same size. This provides a greater uniformity of dose. A fine particle size is essential in case of lubricant mixing with granules for its proper function

What are the Equipments:Fluid energy millCo-milBall millHammer millCutting mill etc.

Granulation:Granulation: A size enlargement process that converts small particles into physically stronger & larger agglomerates

Type of Granulations:

Wet GranulationsDry GranulationsDirect Compression

What are the Equipments:Wet Granulation (Sifter, Rapid Mixer Granulators & Fluid Bed Dryer)Dry Granulator (Roller compactor, Tableting machine)Direct Compression (Sifter & Blender)

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Drying:Purpose: To reduce the moisture level of wet granules

What are the Equipments:

Vacuum tray dryersFluid Bed Dryer

Blending:Blending is the most difficult operation in the manufacturing process since perfect homogeneity is practically impossible due to differences in size, shape and density of particles

What are the Equipments:

V BlendersOctagonal BlendersBin BlendersDouble cone Blenders

V cone blenderOctagonal blenderDouble cone blender

Compression:Principle: : Powder/granules are pressed inside a die and compressed by two punches into required size, shape and embossing.

What are the Equipments:

Tablet Compression Machine

Coating:Principle: Application of coating solution to a moving bed of tablets with concurrent use of heated air to facilitate evaporation of solvent.

What are the Equipments:

Pan (standard/perforated) Coating MachinesFluidized Bed Coating MachinesSpray Coating MachinesVacuum, Dip & Electrostatic Coating Machines

Inspection:Major defects: Broken tablets, cracks or fragments. Capping/ lamination. Crack or porous surface. Excess surface powder Foreign odorTablet with illegible or missing embossing. Sticking. Non-uniform color (Mottling).Minor defects: Adhering surface spots PickingChips Surface not smoothPoor embossing (shallow , broken)Projected edges.

Packaging:Pharmaceutical packaging has to be carried out for the purpose of the safety of the pharmaceutical preparations in order to keep them free from contamination, prevent microbial growth, and ensure product safety throughout the shelf life for the pharmaceuticals. Packaging is done in a contamination free environment or Clean room.

What are the Equipments:

Blister Packing Machine Bottle Filling Machine Strip Packing Machine Pouch Packing Machine

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