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Pharmaceutical Packaging tablet and capsules

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Different types of packaging of tablet and capsules.

Publicada em: Saúde e medicina
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Pharmaceutical Packaging tablet and capsules

  1. 1. Packaging of tablets, capsules and powders. Sonali Dhokne M.Pharm 2nd sem. Rungta college pharmaceutical sciences and research, Bhilai.
  2. 2. Previous year questions from this topic: 1. Discuss functions of packaging. Give an account on influence of packaging component on dosage form stability. 2. Discuss in detail with diagram about packaging of tablets. 3. Write short note on Packaging of capsules. 4. Give detail concepts of packaging of- a) Tablet dosage form b) Powders and capsules 5. Describe the various materials used for containers. Explain tamper evident packing. What are the safety requirements and processing for pacakaging?
  3. 3. Packaging Definition: Packaging is the science, art and technology of enclosing, protecting a product and providing information about the product for distribution, storage, sale and use. Role of packaging:  Protection  Identification  Information transmission  Storage  Convenience
  4. 4. Types of packaging for tablets and capsules: 1. Blister package 2. Strip package 3. Alu-alu packaging 4. Bottle packaging Materials Critical properties Area of use HDPE Container Good barrier for moisture, gas and light. All kind of products from solid orals and dry syrup PET/PP (Amber) Moderate barrier to moisture and gas Light sensitive products.
  5. 5. Materials Water vapour permeation rate (g/m2/day) PVC 250 3 Polypropylene 1 PVC/PVdC (250/40) 075 PVC/ PVdC (250/60) 0.5 Alu-Alu 0 Water vapour permeation rate of some materials used for blister packs.
  6. 6. 1.Blister Package: Blister packs are commonly used for unit dose packaging for tablets and capsules. The principal components of a blister pack comprise of : 1. Forming film (blister): A pocket inside which the product fits and 2. Backing : The lidding foil sticked over the back of a blister.
  7. 7. Materials used for forming films (blisters) : 1. Polyvinyl chloride/polyethylene combinations 2. Polystyrene 3. Polypropylene 4. Polyvinyl chloride (mostly used) For added moisture protection, polyvinylidene chloride (Saran) or polychlorotrifluoroethylene (Aclar) films may be laminated to PVC. The moisture barrier of PVC (Aclar) is superior to that of saran coated PVC especially under prolonged and extremely humid storage. (*- g loss/24hr/100sq in/ mil at 95°C, 95% RH.) Material Water vapour permeation* Aclar (22A, 1mil) 0.055 Saran (PVdC) 1 mil 0.200
  8. 8. Materials used for backing: 1. Paper 2. Paper-aluminium combinations 3. Aluminium foil Backing material can be either,  Push-through type  Peelable type (used for making child resistant packing)
  9. 9. Materials Critical properties Area of use. PVC 200/250/350 Low barrier, simple unit pack Stable products like paracetamol, cotrimoxazole and certain soft gelatin capsules. Aluminium foil / poly (30 –40 microns (soft tempered) Excellent barrier For strip packing use of very sensitive range of products – Omeprazole Capsules, Ranitidine Tablets etc., Alu/Alu with desiccant Excellent barrier Extremely moisture sensitive range of products. PVC / PVdC (250/60)/ (250/90)/ (250/120) Good barrier Moderate to high sensitive range of products, certain FDC/ Enzyme products
  10. 10. Steps involved in the formation of a blister: 1. Thermoforming: This involves heat softening a sheet of thermoplastic resin and then vacuum drawing the softened sheet of plastic into a mold. After cooling, the sheet is released from the mold. 2. Filling: The sheet then proceeds to the filling station for filling. 3. Sealing: Sealing is then accomplished by lidding it with a heat sealable backing material.
  11. 11. 2.Strip Package A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping rollers. This package is used for both capsules and tablets. Materials used:  Foil laminations (for moisture sensitive products)  Paper  Polyethylene  Cellophane (Transparent plastic film formed from processed cellulose)
  12. 12. Steps involved in the formation of a strip package: 1. The product is fed into the pocket formed between two heat sealable flexible films. 2. Sealing is accomplished by heat crimping rollers 3. The strip is then cut into desired no. of packets in length.
  13. 13. 3.Alu-alu packaging Alu-alu packing means aluminium foil at both the upper and lower side of pack. Alu- alu packaging is similar to that of blister packing the only difference is that the forming film is formed of aluminium foil instead of plastic material.
  14. 14. 4. Bottle packaging Bottles are commonly used for liquid pharmaceuticals as well as for tablets and capsules. Materials used: Bottle:  Polyethylene  Polypropylene screw cap  Polystyrene Bottle mouth seal:  Aluminium foil
  15. 15. Dessicants: • Desiccants have been utilised to control the exposure of products to the ingress of moisture. • Amount of dessicant required depends on the below mentioned 2 parameters: 1. Water vapour transmission rate of the container. 2. Rate of moisture absorbed by dessicant.
  16. 16. Dessicant Critical properties Area of use Silica gel bags Desiccant will effectively alleviate moisture and odor problems. Moisture sensitive products Activated carbon Desiccant will effectively alleviate moisture and odor problems. Product which release odor / gas
  17. 17. Packaging of powders • Powdes are solid dosage form comprising of a large number of finely divided solid particles of drugs or mixture of drug and excipients. • Powder packaging can be of following types-  Pouches  Bottles (dusting powders)
  18. 18. a. Pouches: A flexible pouch is usually formed during the product filling operation by either -  Vertical forming/filling/sealing (f/f/s) operation.  Horizontal forming/filling/sealing (f/f/s) operation. Materials used for pouches:  Foil  Paper  Plastic Sealants used:  Polyethylene  Ethylene vinyl acetate(EVA)  Surlyn
  19. 19. Vertical f/f/s operation: A web film is drawn over a metal collar and around a vertical filling tube, through which product is drawn into formed package. Filling tube controls the circumference of the pouch and against which a longitudinal seal is made. The product then drops into the formed tube. The reciprocating sealer moves up the film tube a distance equal to the length of the package and forms the top and the final seal of the package.
  20. 20. Horizontal f/f/s operation: In this system, a web film is folded upon itself rather than around a tube. Then, the vertical sealer seals the film vertically and thus pockets are formed. These pockets are then fed and then sealed horizontally.
  21. 21. Bottles are commonly used for liquid pharmaceuticals as well as for tablets, capsules and powders especially dusting powders. Materials used for bottle: • Polyethylene • Polypropylene screw cap • Polystyrene b. Bottles:
  22. 22. Evaluation of plastic containers: Leakage test for blister and strip packages: Steps invovled: 1. Dip the packages under test in a pot containing coloured water (15-25°C) and place the pot in a vacuum chamber. 2. Apply appropriate vacuum of 33kPa for strip package or 24 kPa for blister package for 30 sec. 3. Return to the atmospheric pressure and remove the pot from the vacuum chamber. 4. Take away the test package from the pot and blot off the excess water and examine the package for the ingress of water into the pockets.
  23. 23. Leakage test for plastic containers (injectables and non-injectables): Steps involved: 1. Fill the containers with water and fit the closure. 2. Keep them inverted for 24 hrs. 3. Check for the sign of leakage from the container. Pinholes: 1. Pinholes is a common feature of aluminium foil, minute holes which may be present in the foil. 2. Foils of 0.017 mm caliper and above is recognized as commercially pinhole free. 3. Foil of 0.025 mm caliper can normally be guaranteed, pinhole free. 4. Foils below 0.017mm gradually show an increased no. of pinholes. When a foil is laminated the initial pinholes tends to be filled in and reduces any permeation risk further.

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