Techno

• • Polishing using wax for a sheeny appearance.
• Process for Aspirin enteric coated/Dry granulation:

  1. Raw drug and excipients (lactose, starch, magnesium stearate) are smashed to reduce their size by a rotary cutter mill.

  2. The material is sieved.

  3. The material is mixed by V-cone tumbling mixer.

  4. Press cake of the material is obtained using a roller mill.

  5. The material is smashed again as in step 1.

  6. The granules are processed.

  7. A drug adhesive like Microcrystalline cellulose is added to the granules and mixed again by V-cone tumbling mixer.

  8. The granules are pressed into tablets using a single punch machine.

  9. Tablets are coated using a film coating machine for protection:

  • Waterproofing and sealing to prevent moisture effects with one or more coats (shellac, zein).
  • Subcoating to bond the film coating and enteric coating using CAP, PVAP enteric polymer.
  • Smoothing and final rounding.
  • Finishing and coloring for an elegant appearance.
  • Imprinting for identification codes.
• Process for Paracetamol/Wet granulation:

  1. Raw drug and excipients are smashed to reduce their size by a rotary cutter mill.

  2. The material is sieved.

  3. The material is mixed by V-cone tumbling mixer.

  4. An adhesive is added to the material and prilled.

  5. The material is dried.

  6. The granules are processed.

  7. A lubricant is added to the granules and mixed by V-cone tumbling.

  8. The granules are pressed into tablets using a single punch machine.

  9. Tablets are coated using a film coating machine for protection:

  • Waterproofing and sealing to prevent moisture effects with one or more coats (shellac, zein).
  • Subcoating to bond the film coating to the tablet.
  • Smoothing and final rounding.
  • Finishing and coloring for an elegant appearance.
  • Imprinting for identification codes.
  • Polishing using wax for a sheeny appearance.
• Process for Sodium chloride tablet or enalapril enteric coated tablet/Crystals compression:

  1. The raw drug material is smashed to reduce the size using a rotary cutter mill.

  2. The smashed drug is sieved to unify the size.

  3. The excipients and the drug are mixed by V-cone tumbling mixer.

  4. A drug adhesive is added and mixed again by V-cone tumbling mixer.

  5. The material is pressed to form tablets using a single punch machine.

  6. Tablets are coated using a film coating machine for protection:

  • Waterproofing and sealing to prevent moisture effects with one or more coats (shellac, zein).
  • Subcoating to bond the film coating and enteric coating using CAP, PVAP enteric polymer.
  • Smoothing and final rounding.
  • Finishing and coloring for an elegant appearance.
  • Imprinting for identification codes.
  • Polishing using wax for a sheeny appearance.
• Size reduction in pharmaceutical processes involves reducing large solid unit masses into small unit masses, coarse particles, or fine particles
• Size reduction is also known as comminution, diminution, or pulverisation
• Size reduction can be achieved by two methods: precipitation process and mechanical process
• In the precipitation process, a substance is dissolved in a solvent and then precipitated by the addition of another solvent
• The mechanical process involves subjecting substances to mechanical forces using grinding equipment like ball mills, roller mills, and colloid mills
• Objectives of size reduction include improving appearance, increasing surface area, facilitating absorption and bioavailability, improving stability, facilitating extraction, mixing, and various pharmaceutical preparations
• Advantages of size reduction include content uniformity, uniform flow, effective drying, improved physical stability, improved dissolution rate, and improved absorption rate
• Modes of size reduction include cutting, compression, impact, and attrition
• Classification of size reduction equipment includes crushers, grinders, ultrafine grinders, cutting machines, and colloid mills
• Examples of size reduction equipment are the rotary cutter mill, roller mill, hammer mill, ball mill, fluid energy mill, and colloid mill
• The rotary cutter mill operates on the principle of cutting and is used for size reduction of tough and fibrous materials
• The roller mill operates on the principle of stress and attrition, used for crushing and cracking seeds before oil extraction
• The hammer mill operates on the principle of impact, rotates at high speeds, and is versatile but may have issues with clogging screens and heat generation
• The ball mill operates on impact or attrition, producing fine powders and used for both dry and wet grinding
• The fluid energy mill operates on impact and attrition, reducing powders to 30 mm or less, but is expensive and not suitable for soft, tacky, or fibrous materials
• The colloid mill operates on shearing, preparing colloidal dispersions, suspensions, emulsions, and ointments with particle sizes as small as 3 µm
• The edge runner mill and end runner mill are used for grinding tough materials and plant-based products, with the latter being suitable for fine grinding
• The multi mill is used for wet and dry granulation, pulverization, and finds application in various industries
• Factors affecting the selection of a mill include the nature of raw materials, the nature of the finished product, safety considerations, and economic factors
• Factors related to the nature of raw materials:

  • Hard materials
  • Fibrous materials
  • Friable materials
  • Elastics materials
  • Hygroscopic materials
  • Melting point
  • Particle size of the material
  • Moisture content
  • Thermolability
• Factors related to the nature of the finished product:

  • Particle size
  • Ease of sterilization
  • Contamination of milled product
• Factors related to safety:

  • Explosivity
  • Irritability
  • Toxicity
• Factors related to economy:

  • Cost
  • Power consumption
  • Space occupied
  • Labor cost
• Mixing is a unit operation that results in a randomization of dissimilar particles within a system
• Types of mixtures:

  • Positive mixtures: formed from miscible liquids and gases that mix spontaneously
  • Negative mixtures: formed from components that tend to separate out, like emulsions, creams, and suspensions
  • Neutral mixtures: components have no tendency to mix or segregate spontaneously once mixed, like pastes and ointments
• Powder mixing equipment:

  • Tumbling mixers: used for mixing granules and free-flowing powders, examples include double-cone mixer, twin-shell mixer, cube mixer
  • Fluidized-bed mixers: used to mix powders prior to granulation, efficient mixing process where powder particles are fluidized in a stream of air
  • Agitator mixers: depend on the motion of a blade or paddle through the product, examples include ribbon mixer and planetary mixer
• Mixers with narrow clearances and a high degree of shear mixing are recommended for materials that do not flow easily, leaving dead spots. Examples include planetary mixers and sigma blade mixers
• Sigma blade mixer:

  • Mechanism of mixing is shearing
  • Consists of a stationary bowl and two sigma-shaped blades fitted horizontally in the bowl
  • Blades are connected to a fixed-speed drive
  • Material is sheared between the blades and walls of the bowl
  • Used for mixing semisolids and in the wet granulation process
• Tablets are solid dosage forms consisting of active ingredients and pharmaceutical excipients. They can vary in size, shape, weight, hardness, thickness, disintegration, dissolution characteristics, and other aspects
• Advantages of tablets:

  • Large-scale production at low cost
  • Easy to package and ship
  • High stability
  • Easy handling for users
  • Light and compact
  • Precise dosing with low content variability
• Disadvantages of tablets:

  • Some drugs resist compression into dense compacts
  • Drugs with poor wetting, slow dissolution, or large dosages may be difficult to formulate
  • Bitter taste drugs, drugs with objectionable odors, or sensitive to oxygen or moisture may require special handling like encapsulation or coating
• Types of tablets:

  1. Compressed tablets

  2. Sugar-coated tablets

  3. Film-coated tablets

  4. Enteric-coated tablets

  5. Effervescent tablets

  6. Chewable tablets

  7. Dispersible tablets

  8. Sustained-release tablets

  9. Multilayer tablets

  10. Sublingual tablets

  11. Troches

  12. Buccal tablets

  13. Implant tablets

  14. Hypodermic tablets

  15. Solution tablets

  16. Vaginal tablets
• Excipients for compressed tablets:

  • Diluents: increase volume, e.g., lactose, dextrin
  • Binders: promote adhesion, e.g., starch, gelatin
  • Lubricants: reduce friction, e.g., talc, stearic acid
  • Disintegrators: promote tablet breakup for dissolution
  • Wetting agents: reduce surface tension for uniform wetting
• The mixer used to mix powders prior to granulation can be:

  • V-cone tumbling mixer
  • Ribbon mixer
  • Fluidized bed mixer
  • Octagonal blender
• The main components of single-punch tablet presses are:

  • Hopper
  • Feed shoe
  • Lower punch
  • Die
  • Upper punch
  • Tablet weight
  • Tablet ejector
  • Adjustor table
  • Hardness adjustor
  • Die cavity
• Wet grinding is used in the preparation of:

  • Eye drops
  • Eye ointments
  • Enteric coated granules
  • Soft capsules