Aerosols

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Aerosols

  1. 1. BUSHRA RUBAB
  2. 2. AEROSOLS  Aerosols are defined as a disperse phase system in which solid particles or liquid droplets constitute the disperse phase and gas in the continuous phase.
  3. 3. HISTORY  In 1942, First aerosol was developed. (insecticide)  In1950, Pharmaceutical aerosol for topical administration was developed.  In 1955, Aerosol for the local activity in the respiratory tract was developed (Epinephrine).
  4. 4. COMPONENTS OF AEROSOLS Propellant Container Valve Actuator
  5. 5. PROPELLANT  The propellant is responsible for develop pressure within an aerosol system to expel material from the container. TYPES OF PROPELLENT Liquefied gas propellant • gases that exist as liquids under pressure. • liquid volume is increased. Compressed gas propellant • occupy the head space above the liquid in the can. • No increased in liquid volume.
  6. 6. CONTAINER  They must be able to withstand pressures as high as 140 to 180 psig (pounds per sq. inch gauge) at 130 ° F. TYPES OF CONTAINERS Metals • Tin-plated steel • Aluminum • Stainless steel Glass • Uncoated glass • Plastic coated glass
  7. 7. VALVES  Easy to open and close .  It can deliver a given amount of medicament. TYPES OF VALVES CONTINIOUS SPRAY VALVE • Used for topical aerosols METERING VALVE • Used for dispensing of potent medication.
  8. 8. ACTUATORS  These are specially designed buttons which helps in delivering the drug in desired form. TYPES OF ACTUATORS SPRAY ACTUATORS • used for topical preparation. • antiseptics, local anesthetics, spray on bandages etc. FOAM ACTUATORS • consist of large orifice which ranges from 0.070-0.125 inch . SOLID STEAM ACTUATORS • for dispensing semi solid products such as ointments. SPECIAL ACTUATORS • deliver the medicament to the appropriate site of action such as throat, nose, dental and eyes etc.
  9. 9. FORMULATION It consist of two essential components :  Product concentrate  Propellant Product concentrate : •Active ingredient or mixture of active ingredients and other necessary agents such as solvents, anti oxidants and surfactants. Propellant : • Single or blend of various propellants is used. • Blend of solvents is used to achieve desired solubility characteristics. •Since the opening of valve is smaller 0.018-0.030 inches, limits the production and process become slow •But with use of rotary filling machine, the production rate is increased
  10. 10. JAVERIA RAHAT
  11. 11. CONTAINER OF AEROSOLS
  12. 12. CONTAINER  Container must withstand pressure 140-180psig at 130F Metal container • Tin plate steel • Aluminum • Stainless steel Glass container • Plastic coated glass
  13. 13. TIN PLATE STEEL CONTAINER  Tin-plated steel containers are light weight and relatively inexpensive. For some products the tin provides all the necessary protection.  However when required, special protective coatings are applied to the tin sheets prior to fabrication so that the inside of the container will be protected from corrosion and interaction between the tin and the formulation.  The coating usually is an oleoresin, phenolic, vinyl, or epoxy coating. The tin plated steel containers are used in topical aerosols.
  14. 14. ALUMINUM CONTAINER
  15. 15. STAINLESS STEEL CONTAINERS  Stainless steel is used when the container must be chemically resistant to the product concentrate. The main limitation of these containers is their high cost.
  16. 16. GLASS AEROSOLS CONTAINERS  glass containers are used in products that have lower pressures and lower percentages of propellants.
  17. 17. PLASTIC COATING GLASS CONTAINER  Glass can be used for various purposes like: Resistance to breakage prevent the glass from shattering into fragments if broken protect the contents from ultraviolet light act as a means of identification since the coatings are available in various colors.
  18. 18. PREPARATION OF PRODUCT CONCENTRATE  The aerosol concentrate consists of drug or combination of drugs, solvents, antioxidants and surfactants formulated as solution, suspension .  The aerosol concentrate is first prepared and filled into the container.  The propellant is then filled into the container. Therefore, part of the manufacturing operation takes place during the filling operation measures to ensure that both concentrate and propellant are brought together in the proper proportion.
  19. 19. UROOBA IQBAL
  20. 20. VALVES • Capable of delivering the content in the desired form such as spray, foam, solid stream etc. TYPES OF VALVES Continuous Spray Valves Metered Valves
  21. 21. CONTINUOUS SPRAY VALVE  Used for topical aerosols .
  22. 22. VALVE ASSEMBLY  Valves assembly consists of:  Ferrule or mounting cup  Valve body or housing  Stem  Dip tube  Gasket  Spring
  23. 23.  FERRULE OR MOUNTING CUP : • Used to attach valve to container. • Made from Tin plated steel, Al , Brass . • Under side of the valve cup is coated with single or double epoxy or vinyl resins.  VALVE BODY OR HOUSING : • Made up of Nylon or Derlin and contains a opening at the point of attachment of dip tube.  STEM : • Made from Nylon or Derlin , brass and stainless steel can also be used.  GASKET : • Made from Buna-N and neoprene rubber.  SPRING : • Made from Stainless steel . • Used to hold gasket in place.
  24. 24. METERING VALVES  DIP TUBE : • Made from Poly ethylene or poly propylene. • Inner diameter 0.120 – 0.125 inch. • However for Capillary dip tube inner diameter is 0.050 inch and for highly viscous products it is 0.195 inch. •Used for dispensing of potent medication. • Operates on the principle of a chamber whose size determines the amount of medication dispensed. • Approximately 50 to 150 mg ±10 % of liquid materials can be dispensed at one time with the use of such valve.
  25. 25. ACTUATORS  These are specially designed buttons which helps in delivering the drug in desired form i.e., spray, wet stream, foam or solid stream .
  26. 26. TYPES OF ACTUATORS Spray actuators Foam actuators Solid steam actuators Special actuators
  27. 27.  SPRAY ACTUATORS: • It can be used for topical preparation, such as antiseptics, local anesthetics and spray on bandages etc. • It allows the stream of product concentrate and propellant to pass through various openings and dispense as spray.  FOAM ACTUATORS : • It consist of large orifice which ranges from 0.070—0.125 inch .  SOLID STREAM ACTUATORS : • These actuators are required for dispensing semi solid products such as ointments .  SPECIAL ACTUATORS: • These are used for a specific purpose. • It delivers the medicament to the appropriate site of action such as throat, nose, dental and eyes etc.
  28. 28. NIDA ASHRAF
  29. 29. PHASES OF AEROSOLS There are two phases of aerosols: • Two phase system/solution system • Three phase system/water based system
  30. 30. TWO PHASE SYSTEM/SOLUTION SYSTEM  Formed by using liquefied gases in the form of propellants  Simplest system  The two phases are: Liquid phase Vapor phase
  31. 31. Product concentrate is dissolved in liquefied propellant This solvent creates a homogenous system. Co-solvents are added to enhance the solubility of the active ingredients.
  32. 32. Advantages To produce a fine mist or wet spray To formulate aerosols for inhalation nasal application
  33. 33. 1: A layer of water immiscible liquid propellant 2: A layer of highly aqueous product concentrate 3: The vapor phase. THREE PHASE SYSTEM OR WATER BASED SYSTEM  The three phases are:
  34. 34. Purpose when the formulation requires the presence of a liquid phase that is not propellant miscible. If CFCs, HCFCs, and HFCs are used as the propellants, they will reside on the bottom of the container. • since their density is greater than water. If hydrocarbons are used as the propellants, they will reside on the aqueous layer. • since their density is less than water
  35. 35. In this phase, three systems are formed:
  36. 36. Water Based System Active ingredient is insoluble in propellant. Surfactants are used (conc. 0.5-2%) Propellant conc. 25 – 60% Water act as base
  37. 37. Dispersion System Active ingredient is insoluble in water and propellant Active ingredient is dispersed in the form of suspension Particle size should be less than 5μm
  38. 38. Foam System Propellant conc. 6-8% Consist of emulsion of propellant +water +drug + emulsifier If the propellant is in the internal phase , a stable foam is discharged, if the propellant is in the external phase, a spray or a quick- breaking foam is discharged.
  39. 39. ANUM ASLAM
  40. 40. FILLING OPERATIONS
  41. 41. FILLING OPERATIONS Cold Filling FOR NON AQUEOUS PRODUCTS OR PRODUCTS WHICH CAN WITHSTAND LOW TEMP (-40F), INCLUDES CHILING OF PROPELLENT AND PRODUCT CONCENTRATE Pressure Filling CARRIED OUT AT ROOM TEMPERATURE BY UTILIZING PRESSURE EQUIPMENTS
  42. 42. COLD FILLING APPARATUS  Consist of an insulated box fitted with coiled copper tubing to inc the area exposed to cooling.  The insulated box should be pre filled with acetone or dry ice, that functions as a refrigerating system.
  43. 43. COLD FILLING PROCESS PRODUCT CONCENTRATE +PROPELLLENT INTO EQUALLY COLD AEROSOLE CONTAINER Propellant is Chilled to a temp of 30-40F Product Concentrate Chilled To a Temp of 30- 40F THE VALVE ASSEBLY IS INSERTED AND CRIMPED INTO PLACE DISPLACEMENT OF INSIDE AIR OF THE CONTAINER BY PROPELLENT VAPOURS
  44. 44. AEROSOL FILLING
  45. 45. ALTERNATIVE METHOD CHILL BOTH CONCENTRATE + PROPELLENT IN A PRESSURE VESSEL TO -40F ADD MIXTURE TO AEROSOLE CONTAINER THE VALVE IS PLACED AND CRIMPED ON TO THE CONTAINER
  46. 46. ADVANTAGE DISADVANTAGES
  47. 47. TESTING PASSING THE CONTAINER INTO HEATED WATER BATH HEAT THE CONTENTS UPTO 130 C IF NO BUBBLE FORMATION, AEROSOLE CONTDRIEDAINERS ARE, CAPPED AND DISPENSED
  48. 48. NAJAF FAROOQ
  49. 49. PRESSURE FILLING
  50. 50. PRESSURE FILLING • It consists of a pressure burette capable of metering small volume of liquefied gas in to aerosol container under pressure. • Propellant is added from inlet. • The propellant is allowed to flow with its own vapor pressure in the container through aerosol valve. • The trapped air escapes out from the upper valve • Propellant stop flowing when the pressure of burette and container becomes equal. • Additional propellant may be added by increasing the pressure in the filling apparatus through the use of compressed gas or nitrogen gas
  51. 51. pre PRESSURE BURRETTE
  52. 52. PROCESS Through the opening of valve propellant is added. The trapped air in the container is removed before adding the propellant. Valve is placed in the container and crimped Filling of concentrate at room temperature
  53. 53. EXCEPTION Since the opening of valve is smaller 0.018-0.030 inches, limits the production and process become slow. But with the introduction of the rotary filling machine, the production rate is increased. Trapped air should be removed.
  54. 54. ROTATORY FILLING
  55. 55. COMPRESSED GAS FILLING Compressed gases are present under high pressure in cylinders. These cylinders are fitted with a pressure reducing valve and a delivery gauge A flow indicator is also present
  56. 56. PROCESS Gas stop flowing when pressure become equal. Nitrous oxide and carbon dioxide is used if more gas is required. Air is removed with the help of vacuum pump. Gas is allowed to flow from filling head. The concentrate is placed in the container. Valve is placed in the container
  57. 57. ADVANTAGES It is the preferred method for solutions, emulsions and suspension No refrigeration is required, can be carried out at room temperature. Less propellant is lost. Less chances of contamination.
  58. 58. DISADVANTAGES Certain metering valves cannot handled due to pressure Slower process than cold filling
  59. 59. RABIA KHALID NADEEM
  60. 60. PACKAGING OF AEROSOLS A unique aspect of pharmaceutical aerosols as compared to other dosage forms is that the product is actually packaged as part of the manufacturing process.  Most aerosols have a protective cap that fits snugly over the valve & mounting cap.  this protect the valve against contamination with dust & dirt  The cap which is generally made up of plastic or metal also serves a decorative function .
  61. 61. STORAGE  Expose to temp. above 49 C (120 F) may burst an aerosol container.  When the containers are cold less than the usual spray may result.  These products are generally recommended for storage between 15C - 30C (59F & 86F)
  62. 62. LABELING  Medicinal aerosols are labeled by the manufacturer with plastic peel-away labels or easily removed paper labels.
  63. 63.  Aerosols have special requirements for use & storage:  For safety, labels must warn users not to use or store them near heat or an open flame.  Aerosols are labeled with regard to shaking before use & holding at the proper angle.
  64. 64. Proper Administration & Use Of Pharmaceutical Aerosols  The pharmacist should make every attempt to educate the patient about aerosol dosage forms.  The pharmacist should provide the patient written as well as verbal instructions for proper use.
  65. 65. ORAL METERED AEROSOLS  The patient should be told how to hold it & how to use it properly?
  66. 66. EXTENDER DEVICE  If the patient can not use the inhaler it is advisable for the pharmacist to recommend to the patient or the patient’s physician the use of an extender device with the inhaler.  They can effectively assist the delivery of medication .
  67. 67. TOPICAL ADMINISTRATION  The patient should first clean the affected area gently & pat it dry.  Holding the canister with the nozzle pointing towards the body area.  Then press down the button to deliver enough medication to cover the area.  Not cover the area with the bandage or dressing unless instructed to do so.
  68. 68. VAGINAL & RECTAL AEROSOLS  The foams are used intravaginally  Inserter filled with foam & placed in the vagina through activation of the plunger .
  69. 69. NAMEERA AHMED
  70. 70. PROPELLAN TS VALVES, ACTUATORS , DIP TUBES CONTAINER S WEIGHT CHECKING LEAK TESTING SPRAY TESTING QC TESTING
  71. 71. PROPELLANTS Vapor pressure, density, purity & acceptability of the propellant are determined & compared with specification sheet.
  72. 72. VALVE,ACTUATORS,DIP TUBES •Valve acceptance, delivery rate •Sampling is done according to standard procedures as found in Military Standards “MIL-STD-105D”. •For metered dose aerosol valves ,test methods were developed by: Aerosol Specifications Committee Industrial Pharmaceutical Technology Section Academy Of Pharmaceutical Sciences •The objective of this test is to determine magnitude of valve delivery & degree of uniformity between individual valves. •Standard test solutions were proposed to rule out variation in valve delivery.
  73. 73. Placed 25 valve (container) Actuator Attached Temp -25+-1C Valve actuated (for 2 sec)+weighed Again valve actuated (2 sec)+ wt d/f represent delivery (mg) From 25 test units Repeat it for total 2 individual deliveries. PROCEDURE
  74. 74. • Examined for defects in lining. • Q.C aspects includes degree of conductivity of electric current as measure of exposed metals. • Glass containers are examined for Flaws. •Done by periodically adding to the filling line tarred empty aerosol containers, which after filling with concentrate are removed & weighed. • Same procedure is used for checking weight of Propellants being added. CONTAINERS WEIGHT CHECKING
  75. 75. •Means of checking crimping of the valve & detect the defective containers due to leakage. •Done by measuring the Crimp’s dimension & comparing. •Final testing of valve closure is done by passing the filled containers through water bath. •Most ph aerosols are 100% spray tested. •This serves to clear the dip tube of pure propellant and pure concentrate. •Check for defects in valves and spray pattern. LEAK TESTING SPRAY TESTING
  76. 76. FARAH ALI KHAN
  77. 77. ADVANTAGES OF AEROSOLS Drug delivery is targetted Fewer side effects Rapid response of the drug
  78. 78. Small aerosol doses Ease of Application Self administration
  79. 79. Suitable when drugs degrade in GIT Prevent Oxidation of drugs Maintain sterility and easy to portable
  80. 80. DISADVANTAGES OF AEROSOLS Dose estimation is difficult Expensive Flammable Nature
  81. 81. Propellant may cause chillness to the skin Aerosols container must not be exposed to higher temperature Toxicity

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