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Packaging material for various formulations


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Packaging material for various formulations

  1. 1. Presented By Guided By: Mahesh K. Shinde Dr. R. J. Dias HOD, Dept. of Pharmaceutics M.Pharm -II nd sem.  SINHGAD INSTITUTE OF PHARMACEUTICAL SCIENCES, LONAVALA 1
  2. 2. Packaging material for : Solid dosage form Liquid dosage form Sterile products Ophthalmic dosage form Transdermal drug delivery system Transnasal drug delivery devices 2
  3. 3. Glass Bottles• type III glass and NP glass is used.• Transparent and Amber coloured glass bottle• It have strong and rigid• Impermeable to water vaporsPlastic Bottle :• Bottles made from polyethylene (HDPE), Polypropylene , Polystyrene .• It is light weighted and non breakable. 3
  4. 4. Blister packaging:The primary component of a blister pack is a cavity or pocket made from a formable web, usually a thermoformed plastic and a backing membrane or a "lidding" seal of aluminum foilThe most basically Polyvinyl chloride (PVC) usedfor forming cavity or pocket.Others materials used - polychloro-trifloro-ethylene - cyclic olefin copolymers for moisture prevention 4
  5. 5. Strip Packaging1. Strip packs present an alternative form of pack for a unit dosage.2. This pack consists of one or two plies, made fromregenerated cellulose, paper, plastic, foil or combinationof these3. The use of high barrier material like aluminum foil orsaran-coated film with excellent seal formation formoisture-sensitive products.4. cellophane film -. -when transparency required. 5
  6. 6. Tests of strip and blister packaging1) Leakage testing and package integrity testingDip the packages in the pot containing the colored water and place the pot in the vacuum chamber. Apply the vacuum for strip packages and for blister packs for 30 sec . Return to the atmospheric pressure and remove the pot from the vacuum chamber. Examine the package for ingress of the water in to the package2) Pinholes and package integrity Pinholes are the common features of aluminum foil. It can be detected by water vapor permeation. High water vapor permeationindicates the high numbers of the pinholes. 6
  7. 7. Pouches Plastic Pouches :1. Made from strong LDPE film2. With a re-sealable strip at the top, easy toopen and close Plastic Pouches3. It have Waterproof, tide proof, air proof and non-poisonous property .Especially suitable for hospital and clinicAluminum pouches :1. It have tear strip facility Aluminium pouches2. It offers excellent barrier properties to themoisture, gas and light 7
  8. 8. Solids-Rectal (Suppository) :1) Aluminum Foil • Offers the highest possible protection against moisture, oxygen, and light,. • the aluminum suppository package takes the shape of individual doses . • Aluminum foil quality offers protection even under the most difficult climatic conditions. • It serves Child resistant due to Non-transparent material • Excellent appearance • Have an easy opening feature with a peelable system, and tearing 8
  9. 9. 2) Laminates for suppositories :• It is made of Polyolefine, Aluminum, P.E. .• It gives protection from moisture, gas ,vopours,light• The product is smooth, easy to tear, shape well, particularly suitable for temperature & humidity- sensitive suppository,• It directly contacts suppository medicines, no abnormal toxicity, no physical and chemical matrix effects occurred 9
  10. 10. Solids (Inhalation) Dry-Powder Inhaler :• It is made of plastics such as polyethylene (HDPE), Polypropylene , polystyrene .How to use:1. Hold the base of the inhaler firmly and open the inhaler by turning the mouth piece in the direction of the arrows.2. Take a capsule out of the blister strip and. Place the capsule into the capsule cavity .3. Close the mouthpiece back to the closed position4. Press the bottom buttons with thumb and index finger at the same time . So that capsules are puncture & powder is dispersed .5. Insert the mouthpiece of the inhaler completely into your mouth, behind your teeth and on your tongue. Close your lips tight round the mouthpiece And Breathe in rapidly but steadily, as deeply as you can. 10
  11. 11. - Glass Or Plastic Bottle- Bottle With Spray Pump 1)Capacity: 50ml 2) Material: Bottle-polyethylene terephthalate; Sprayer-polypropylene 3) Spray output: 0.05ml-0.20ml 4) Bottle is tough , excellent strength and have gas & aroma barrier 5) Used for body spray, oral spray, anti-bacterial 11
  12. 12. Bottle With Dropper Assembly :• Dropper assemblies can be supplied with coloured caps• glass type II is used• Dropper glass is of Sodalime glass(type III) and Neutral glass(type I).• Bottle capacity is from 2 to 100ml• pipettes are up to 120mm in length 12
  13. 13. Collapsible tubes :• It is made of metals like aluminum , tin and lead and plastics like low density polyethylene• Material for cap is of high density polyethylene, polypropylene and pvc.• Adv. Of metal collapsible tube - risk of contamination of portion remaining in the tube is minimum because inner material is not suck back 13
  14. 14. Collapsibility test for Injectable and Non-Injectable preparation( IP1996)-This test is applicable for those containers, which have to be squeezed for thewithdrawal of product.A container by squeezing yields at least 90% of its nominal contents at requireflow rate at ambient temperature. 14
  15. 15. Aerosol spray :Container: To withstand pressure 140-180 psig1) Tin plate container- it is sheet of steel plates electroplated on both side with tin2) Aluminum container- it has seamless nature and greater resistance to corrosion (corroded by pure water and pure ethanol)3)Stainless steel container –used inhalation aerosol - No coating required -extremely strong and resistant to most matter4)Glass container – type I glass is usedValve1) Mounting cup / ferrule –tin plate steel, Aluminum, Brass - it is used to attach the valve proper to container2) Valve body/Housing – it is opening at the point of attachment of the dip tube. -- Nylon or delrin 15
  16. 16. Dip tube –allows the liquid to enter the valve - Polyethylene and polypropyleneGasket - it is seal between the valve cup and aerosol can . -Buna N and Neoprene rubberStem -Nylon and Delrin or metal like Brass , stainless steelSpring -Hold gasket in placeActuator – is used to delivered the product types of actuator1) Spray – orifice is 0.016 – 0.040 inch in dia.2) foam – orifice is 0.070- 0.125 inch in dia. 16
  17. 17. Test of aerosolValve acceptance : The test procedure of metered valve having thefollowing value: 54µL or less, the limits are +/- 15% 55 to 200µL, the limits are +/- 10%1) Of the 50 individual deliveries, if four or more are outside the limits, the valves are rejected.2) If three or two deliveries are outside the limits, another 25 valves are sampledand test is repeated. The lot is accepted if not more than one delivery is outsidethe specificationsWeight checking: : This is usually accomplished by periodically adding to the emptyaerosol containers, which after being filled with concentrate, are removed andaccurately weighed to check the accuracy of filling operation. 17
  18. 18. Leak testing : The testing of efficiency of the valve closure is accomplished by passingthe filled containers through the water bath. Periodic checks are made of thetemperature of the water bath and the results are recordedSpray testing: : This method is based on the impingement of the spray on the paper thathas been treated with a dye-talc mixture. The particles that strike the paper causedye to go into solution and to be absorbed onto the paper. This gives the recordof spray. 18
  19. 19.  Glass Ampoules :• Type I (borosilicate glass is used)• Packaging is 100% tamper proof.• One point or colour break ring offers consistent breaking force.• Up to 3 colour can be placed for identification purpose.• PVC mono films used for 20 packaging. MINIMUM TYPE OF FORMULATION QUALITY OF PACKAGE TYPE CAN BE PACKED GLASS THAT CAN BE USED Aqueous Injectables Of Any Type I pH Aqueous Injectables Of pH Ampoule Type II Less Than 7 Non-Aqueous Injectables Type III 19
  20. 20. Sealing of ampoule:1) Tip sealing - seal is made by melting sufficient glass at the tip of the ampouleneck to form bead of the glass and close the opening.2) Pull seals - seals are made by heating the neck of rotating ampoule below thetip, then pulling the tip away to form small, twisted capillary prior to being melted closed• Now a days, plastic ampoules for “water for injection” are available in the market. 20
  21. 21. Vial With Stopper :• Vials are mainly used for multiple dose parenteral preparation and are provided with the closure followed by aluminum seal to ensure the perfect air tight packing Aqueous Injectable Of Any pH Type I Aqueous Injectables Of pH Less Vial Type II Than 7 Non-Aqueous Injectables Type IIIClosure:• Made from Butyl rubber ,Nitrile rubbers ,Neoprene, Silicon rubbers.• It has compression recovery, coring resistance, solvant resistance, heat resistant , radiation resistance with very low 21 water absorption and permeability properties.
  22. 22. Test of closure1) Fragmentation test : Place a volume of water corresponding to nominal volume minus 4 ml in each of 12 clean vials. Close the vial with closure and secure caps for 16 hours.Pierce the closures with 21 SWG hypodermic needle (bevel angle of 10 to 14) and inject 1 ml water and remove 1 ml air. Repeat the above operation 4 times for each closure (use new needle for each closure). Count the number of the fragments visible to the naked eye. Total numbers of the fragments should not be more than 10 except butyl rubber where the fragments should not exceed 15. 22
  23. 23. 2) Self sealability test for rubber closure applicable to multidose containersonly. Fill 10 vials with water with nominal volume and close the vials with closure, secure the cap. Pierce the caps 10 times at different sites with 21 SWG hypodermic needle. Immerse the vials in 0.1% w/v methylene blue solution under reduced external pressure (27K Pa) for 10 mins. Restore the normal pressure and keep the container immersed for 30 mins. Wash the vials. None of the vials should contain trace of colored solution3) Closure efficiencyPutting liquid in pack, inverting and applying a vacuum. A poor seal is detected by liquid seeping. 23
  24. 24. - Pre-Filled Syringe:• It is used for small volume parenteral preparation.• Reduction of medication errors like drug overfill.• It gives Increased assurance of sterility 24
  25. 25. Blow-fill-seal Technology :• The basic concept of blow fill seal (BFS) is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine.• Plastic containers are made up of polyethylene and polypropylene.• Polypropylene is more commonly used for containers because it has greater thermo stability which is further sterilized by autoclaving. 25
  26. 26. A ) Thermoplastic resin is extruded into a tubular shape called a parison.B) When the parison reaches the proper length, the mold is closed and the parisonis cutC)The blow-fill nozzle is lowered into the parison and by blowing sterile filteredcompressed air into the parison and expanding it against the walls and the sterile product is metered into the container through the fill nozzle.D) Mold comes close at the top and hermetically seal the container.E)The mold opens, and the formed, filled and sealed container is conveyed out of the machine 26
  27. 27. Sterile plastic devices :Irrigation solution container :• It is made of LDPE , Polyolefin , polypropylenes• Avoid hanging breakable glass• It is light in weight, transparent, impermeable to water• Material have high boiling point so that it is sterilizable . 27
  28. 28. I.V. Infusion :• It is made of acrylonitrile butadiene styrene• Spike is made of nylon• tube is made of polyvinyl chloride• Niddle adapter is made of polymethacrilate Catheter: • Catheter is inserted into a body cavity, duct, vessels. • It is made of Silicone because it is inert and unreactive to body fluids and a range of medical fluids with which it might come into contact. 28
  29. 29. Disposable syringe :• material used are polycarbonate, polyethylene, polypropylene.• Material used for piston are natural rubbers, butyl rubbers for sliding well• Silicone and floroelastomer is more long lived than butyl rubbers..• They have property of abrasion resistance, radiation resistance, excellent self- life properties. 29
  30. 30. Tests on the plastic containers1 ) Leakage test for Injectable & Non-Injectable(IP 1996) Fill the 10 containers with water and fit the closure. Keep them inverted at RT for 24 hours. No sign of leakage from any container.2) Water vapor permeability test for injectable preparation(IP 1996) Fill the 5 containers with nominal volume of water and seal. Weigh the each container. Allow to stand for 14 days at RH of 60 + 5% at 20 c to 25 c. Reweigh the container. Loss of the weight in each container should not be more than 0.2%. 30
  31. 31. Test Toxicity Evaluation:1) Implanting small pieces of plastic material intramuscularly in rabbits2) Injecting the eluates using the sodium chloride injection with or withoutalcohol intravenously in the mice and injecting the eluates using thepolyethylene glycol 400 and oil intraperetonially in mice3) Injecting all four eluates subcutaneously in rabbitsThe reaction from the test sample must not be significantly grater than nonreactive control sample. 31
  32. 32. 1) Plastic bottles:• Material used for plastic bottle is low density polyethylene, HDPE• Consumers often get too little with each squeeze• LDPE used in ophthalmics usually contains minimal additives• for caps are harder plastic materials such as LLDPE, HighdensityP.E. , or Polypropelene is used. 2) Collapsible Tube 3) blow-Fill-Seal Plastic Bottle 32
  33. 33. • Backing Films -To protect the active layer and safeguard the stability of the system The most common materials used - polypropylene, polyethylene (both high and low density), saran, polyesters, PVC,and nylon.• Semi-Permeable Membranes - act as a rate-limiting membraneMaterial used are Ethylene Vinyl Acetate Membranes (EVA): PolyethyleneMembranes 33 - The permeability depends on the percentage of the EVA - the higher the
  34. 34. Pouching MaterialsThere are three main layers in the composite materialsused for pouches:1) Internal plastic heat sealable layer, - material used -polyethylene, surlyn2) Aluminium foil layer – Its important role in protecting the product from light and oxygen.3) External printable layer. It is used to achieve a better finishing and printing quality material- Paper or polyester film is used 34
  35. 35. Tests of T.D.D.S. :1) Thickness : The thickness of transdermal film is determined by traveling microscope, dial gauge, screw gauge, micrometer at different points of the film.2) Uniformity of weight : Weight variation is studied by individually weighing -10 randomlyselected patches and calculating the average weight. The individual weightshould not deviate significantly from the average weight3) Moisture Uptake: Weighed films are kept in a desiccator at room temperature for 24 h. These are then taken out and exposed to 84% relative humidity using saturated solution of Potassium chloride in a desiccator . % moisture uptake is calculated as- 35 % moisture uptake = Final weight – Initial weight X 100
  36. 36. Kurve technology :• By this it is possible to deliver drug to the entire nasal cavity as well as olfactory region and paranasal sinuses• It increases nasal residence time and reduses the deposition of compound in lungs and stomach 36
  37. 37. Opti-nose device :• In this , air is blown out of the container and sealing nozzle is used its direct flow of air in nose• It gives bi-directional flow so that it prevents deposition of drug in lungs. 37
  38. 38. Direct-haler device : for moisture protection Transparenc y of divice for drug visibility for turbulent dispersion of dose 38
  39. 39.  Packaging materials are varies as the dosage form is changes.. By using different packaging device we can target drug to specific site. We can protect the drug from external environment with help of packaging material. 39
  40. 40.  Lachman, Libarman; “The theory and practice of industrial pharmacy”, third edition, varghese publishing house Jain U.K., Nayak S.; “Pharmaceutical packaging technology” PharmaMed Press Dean D.A., Hall I.H.; “Pharmaceutical packaging technology” Taylor and Francis Hanlon F. J., “Handbook of package engineering”, 40
  41. 41.   All 41
  42. 42.   ? 42