1 / 105

documents.pub_36285406-pharmaceutical-aerosol-ppt-562f953047214

Aerosol products

drnophadon
Download Presentation

documents.pub_36285406-pharmaceutical-aerosol-ppt-562f953047214

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. PHARMACEUTICAL AEROSOL K.Senthil kumar M.Pharm Asst.Prof QIS college of Pharmacy,Ongole .Andhra pradesh

  2. INTRODUCTION ?Aerosol is pressurized dosage form in which therapeutically active drug is dissolved or dispersed or suspended in compressed or liquified gas to expel the content from the conatiner in the form of spray ?Aerosol mainly used for the treatment of Asthma and COPD disease etc…. ?Aerosols are used for either topical , oral or nasal administration in the form fine particles or mist or fog. ?In mid 1950 the pharmaceutical aerosol introduced in market.

  3. DRUGS USE IN AEROSOLS

  4. ADVANTAGES ?It produce Rapid action. ?It is suitable for when the degrade in GI tract. ?It Directly applied to the affected area. ?It Prevents to Oxidation of drugs ?It can avoid the hepatic metabolism of drugs. ?It can be maintain sterility& easy to portable ?It produce local & systemic effect( due to large surface area of lung and blood capillary )

  5. DISADVANTAGES ? Limited safety hazard (Flammable Nature) ? It is a Costly Preparation ? It is a chance for continuous deposition of particle in upper respiratory tract ? The propellant may cause chillness to the skin

  6. TYPES OF AEROSOL SPRAY ? There are three types of aerosol spray. 1. Space sprays 2. Surface coating spray 3. Foam spray

  7. SPACE SPRAY ? These products are delivered as a fine mist is called space spray .It contains 85% propellant and it is pressurized at 700F with 30-40 psig. ? It contains not more than 50 µm of particle. So it can be retain in air. eg. Room sprays

  8. SURFACE & FOAM SPRAY ? Aerosols intended for carrying active ingredients to surface are termed as surface sprays or surface coating spray. ? It contains 30 –70% propellant operate between 22–55 psig at 700F. Eg. Topical Aerosol ? Foam aerosols(emulsion ) usually operate between 35 and 55 psig at 21°c and contains only 6-10% propellant.

  9. PHYSIOLOGY OF RESPIRATORY TRACT

  10. ? The main function of respiratory tract is transfer of O2 from inspired air to blood and removal of Co2 from the blood. ? Respiratory tract divided in to two parts 1.Upper respiratory tract { Nose ,throat , pharynx and larynx } 2. Lower respiratory tract {Trachea, bronchi, bronchioles ,and alveoli }

  11. DIAGRAM OF HUMAN AIRWAYS

  12. PARTICLE DEPOSITION IN RPT ? If Particles size >100 µm in diameter may deposit in the oropharyngeal cavity. ? If Particles between 10 to 60µm will be deposited on the epithelium of the bronchial tract. ? If Particles Size is < 2 µm in diameter can reach the alveoli.

  13. AEROSOL CONTAINER

  14. MECHANISM OF PARTICLE DEPOSITION IN RPT ?There are four mechanisms to operate aerosols 1. Interfacial interception 2. Brownian diffusion 3. Gravitational sedimentation 4. Electrostatic precipitation

  15. INERTIAL IMPACTION ? Inertial impaction occurs because a particle traveling in an air stream has its own momentum (the product of its mass and velocity) ? As the direction of the airflow changes due to a bend or obstacle, the particle will continue in its original direction for a certain distance because of its inertia. ? Impaction of particles entering the mouth with a high velocity occurs either at the back of the mouth or at the bend where the pharynx leads to the trachea. Only a small fraction of particles greater than 15 µ m will reach the trachea following mouth breathing.

  16. CONTIN…… Deposition by impaction will also occur as the trachea splits into the left and right bronchus.

  17. GRAVITATIONAL SEDIMENTATION(GS) ? GS is the downward movement of particle under the action of gravity .

  18. CONTIN…. ? If particle size is less than 5µm deposition in bronchioles and alveoli. ? Particles settle by gravitation onto the airway walls. ? It was explained by stokes Law V= 2r2(d1-d2)g 9ŋ

  19. BROWNIAN DIFFUSION ? Collison and bombardment of small particle by the molecule in the respiratory tract to produce Brownian motion.

  20. CONTIN….. ? Brownian motion or diffusion is a mechanism which significantly affects only particles less than 0.5 µ m in diameter ? These particles are subjected to bombardment by surrounding gas molecules causing random movement of the particles. In this situation, the diffusivity of a particle is inversely proportional to its diameter.

  21. INTERCEPTION ? If the particles contact the airway surface because of their larger dimension of particle

  22. ELECTROSTATIC PRECIPITATION ? The charge on the surface of the particle may affect the resultant deposition i.e. Surface of charged particle( + ve ) interact with a site within the respiratory tract that posses on opposite charge (-ve). ? Unipolar charged aerosols with high number concentrations repel each other and drive particles towards the walls.

  23. BREATHING PATTERN ? Breathing pattern ,lung physiology will affect the deposition of particle. ? Breath holding after inhalation enhances the deposition of particle by sedimentation and diffusion.

  24. COMPONENT OF AEROSOL Aerosol consist of 1. Product concentrate 2. Propellant ? Product concentrate consist of API, Additives like suspending agent , emulsifying agent , antioxidant, aqeous and non aqueous ,cosolvent etc…

  25. PROPELLANT It is responsible for developing the vapour pressure with in the container and also expel the product when the valve is opened and in the atomization or foam production of the product. It is classified in to mainly two types 1. Liquified gas system a) Flourinated hydrocarbon(FHC) b) Chloro fluro carbon (CFC) C) Hydrocarbons (HC) 2. Compressed gas system 3.Hydrofluoroalkanes

  26. LIQUIFIED GAS SYSTEM ? These compounds are gases at room temperature and atmospheric pressure .However they can be liquified easily by lowering the temperature (below the boiling point or by increasing pressure ) ? These compounds are chosen generally have B.Pt below 700F and vapour pressure between 14 and 85 psia at 700F ? When it is placed into sealed container it immediately separartes into a liquid and a vapour phase

  27. CONTIN….. ? Some o f the propellant molecule will leave from the liquid state to vapor state.The pressure at this point is called vapour pressure ? It is denoted by the symbol Psia ? As molecule enter the vapor state a pressure gradually develops ? no .of molecule in v.state = vapor pressure

  28. FLUORINATED HYDROCARBONS It is Used for oral and inhalation aerosol preparation. Chemical Name Chemical Formula Numerical Designation Trichloromonoflouromethane CCl3F 11 Dichlorodifluoromethane CCl2F2 12 Dichlorotetrafluroethane CClF2CClF2 114 Chloropentaflouroethane CClF2CF3 115 142b Monochlorodifluroethane CH3CClF2 152 b Difluroethane CH3CHF2 Octaflurocyclobutane CF2CF2CF2CFM212 C318

  29. CONTIN…… ? Psia means = pounds per square inch absolute ? The term psig ( pounds per square inch inch gauge) ? 0 Psig = 14.7 Psia Eg. Flourinated hydro carbon

  30. CHLORO FLURO CARBON( CFC) ?Advantages ?Low inhalation toxicity ?High chemical stability ?High purity ?CFC-11 is a good solvent ?Disadvantages ?Destructive to atmospheric Ozone ?Contribute to “greenhouse effect” ?High cost ? eg. 1.Hydrochlorocarbon 2.Hydroflurocarbon 3. Hydrochloro flurocarbon

  31. HYDROCARBONS Chemical Name Numerical Designation Butane A-17 Isobutane A-31 Propane A-108 It is mainly used for for the preparation of topical preparation

  32. CONTIN…….. ? Chemically stable ? No hydrolysis ? Inflammable ? Low toxicity ? They are lighter than water

  33. COMPRESSED GAS SYSTEM Advantages ?Low inhalation toxicity ?High chemical stability ?High purity ?Inexpensive – No environmental problems ?Disadvantages ?Require use of a nonvolatile co-solvent ?Produce course droplet sprays ?Pressure falls during use Eg.. Co2 , No,N2

  34. HYDROFLUOROALKANES ?Advantages ?Low inhalation toxicity ?High chemical stability ?High purity ?Not ozone depleting ?Disadvantages ?Poor solvents ?Minor “greenhouse effect” ? High cost – e.g. 1,1,1,2,3,3,3 – Heptafluoropropane (HFA-227), 1,1,1,2 – Tetrafluoroethane (HFA-134a)

  35. PHYSIOCHEMICAL PROPERTIES OF PROPELLANTS ? Vapor pressure ? Boiling points ? Liquid density

  36. ? Vapor pressure of mixture of propellants is calculated by Doltan’s law which states that total Pressure in any system is equal to the sum of individual or partial pressure of various compounds ? Raoult’s low regards lowering of the vapor pressure of a liquid by the addition of another substance, States that the dispersion of the vapor pressure of solvent upon the addition of solute is proportion to the mole fraction of solute molecules in solution. ? The relationship can be shown mathematically : na pa = ------------ pAo =NApAo ----------(1) na + nb

  37. AEROSOL CONTAINER ? They must be stand at pressure as high as 140 to 180 psig (pounds per sq. inch gauge) at 1300 F. A. Metals 1. Tinplated steel (a) Side-seam (three pieces) (b) Two-piece or drawn (c) Tin free steel 2. Aluminium (a) Two-piece (b) One-piece (extruded or drawn) 3. Stainless steel B. Glass 1. Uncoated glass 2. Plastic coated glass

  38. AEROSOL CONTAINERS ? Containers must withstand pressure as high as 140 to 180 psig ? Types of containers: 1. Tin plate containers ?consists of sheet of steel plate that has been electroplated on both sides with tin 2. Aluminum containers ?greater resistance to corrosion ?Light weight, not fragile ?Good for light sensitive drugs

  39. Stainless steel container ?Limited for smaller size ?Extremely strong and resistant to most materials ?Pressure stand 4. Glass containers ?Available with plastic or without plastic coating ?Compatible with many additives ?No corrosion problems ?Can have various shape because of molding ?Fragile ?Not for light sensitive drugs

  40. COMPONENT OF AEROSOLS ?Actuator ?Ferrule or mount cap ? Valve body or housing ? Stem ? Gasket ? Spring ? Dip tube

  41. TYPES OF ACTUATOR Actuators: ? These are specially designed button placed on the valve system which helps in easy opening and closing of the valve. ? It helps in deliver the product in the desired form. There are different type of actuators are used , ?Spray Actuators ?Foam Actuators ?Solid Stream Actuators ?Special Actuators

  42. CONTIN….. Spray actuator ? The stream of product concentrate and propellant are dispensed in the form of small particle through orifices 0.016- 0.040inch. ? Large orifice are used when high pressure of propellant 12 Foam Actuator: They contain large orifice diameter 0.070-0.125 inch Semisolid stream actuator: It is used for dispensing semisolid dosage form Special actuator: They are specially designed to deliver the medicament on the specific sites like nose , throat

  43. TYPES OF AEROSOL VALVES 1.Continuous spray valve ? Mounting Cup / Ferrule ? Valve body or Housing ? Stem valve ? Gasket ? Spring ? Dip Tube 2. Metering valve

  44. VALVE ? Regulate the flow of product and discharge the content ? Valve is associated with the help of actuautor (if the foam present in the container) to emitted the product as wet or spray ? continuous spray valve

  45. FERRULE/ mounting cup ? It is used to attach the valve in proper position in container.it is necessary coated with epoxy resin. ? Valve body / housing : ? It is made of nylon/delrin and contains at the opening point of diptube(0.013 to 0.080 inch) ? It prevents clogging of p.size,reduce chilling effect of the skin

  46. ?Stem: it is made of nylon /delrin/s.steel It contains one or more orifice (0.013 to 0.030) Gasket : It is made of Buna –N, Neoprene rubber Spring: It is used to hold the gasket in a place and when actuator is depressed it returns the valve in closed position It is made of stainless steel Dip tube : It is made up of poly propylene material / poly ethylene Inside diameter (0.120 – 0.125) for c.tube ( 0.050 inch and Viscous product 0.195)

  47. TYPES OF AEROSOL SYSTEM There are five types of aerosol system ?Solution system / Two phase system ?Water based system / Three phase system ?Suspension or Dispersion system ?Foam system ?Aqueous stable foam ?Non-Aqueous stable foam ?Quick Breaking Foam ?Thermal foam ?Intranasal foam

  48. SOLUTION SYSTEM ? which consists of two phases: a vapor phase and a liquid phase ? Propellant has high pressure hence propellant 114 is added to reduce its vapour pressure .

More Related