Inhalation and Ear drops (1).pptx

LECTURE 5: INHALATION, NASAL AND EAR DROPS PHARMACEUTICS II (MDPH 2502) DIPLOMA IN PHARMACY  Learning Objectives At the end of the session, the students are able to: Describe the types of dispensed preparations for inhalation, otic and nasal dosage form...

LECTURE 5: INHALATION, NASAL AND EAR DROPS PHARMACEUTICS II (MDPH 2502) DIPLOMA IN PHARMACY  Learning Objectives At the end of the session, the students are able to: Describe the types of dispensed preparations for inhalation, otic and nasal dosage forms. Describe the suitable labeling used for such preparations. Choose the proper packaging for such preparations. DIPLOMA IN PHARMACY MDPH 07/13/2024 2 2502  Inhalations Liquid preparations composed of, or containing volatile substances which, when vaporized in a suitable manner, are intended to be brought into contact with the lining of the respiratory tract. Contain one or more active ingredients → dissolved or dispersed in a suitable vehicle. Used to relieve congestion & inflammation of the respiratory tract. When the active ingredient is volatile at room temperature, can be placed on an adsorbent pad & inhaled from it. Others may be added to water at about 65°C & the vapour 07/13/2024 DIPLOMA INis inhaled PHARMACY MDPH for five to ten3 minutes. 2502  The Inhalation Route of Drug Administration DIPLOMA IN PHARMACY MDPH 07/13/2024 4 2502  The Inhalation Route of Drug Administration To produce either local or systemic effect. Mainly used to treat respiratory conditions like asthma. The onset of drug action is seen immediately as the drug can be delivered directly to the site of action (lungs). Smaller drug dose is required to produce the desired effect than oral route (e.g. salbutamol oral dose is 4 mg & inhaled dose is 0.2 mg). The risk of salbutamol systemic side effects is reduced. Drug absorption from this route is extremely rapid & can be used to produce systemic action. Variety of dosage forms can be used, from simple inhalations to sophisticated inhaler devices. Disadvantages: Inhalation is difficult than swallowing. Some drugs are ineffective by this route (e.g. theophylline). Not more than 20% of the drug reaches the lung. DIPLOMA IN PHARMACY MDPH 07/13/2024 5 2502  Formulation of Inhalations Inhalations intended to be added to hot water may consist of: 1. Simple solutions of medicament, dissolved in alcohol or an alcoholic preparation, or 2. Aqueous dispersions, containing diffusing agent such as light magnesium carbonate, to adsorb & diffuse the volatile ingredient. Vehicle: Water, alcohol, alcoholic preparations. DIPLOMA IN PHARMACY MDPH Diffusing agent: Light magnesium 07/13/2024 2502 6  Method of Preparation Menthol & Eucalyptus Inhalation BP 1980 Formula: Menthol………………………….…….. 2 g Eucalyptus oil……………………........ 10 ml Light Magnesium Carbonate………… 7 g Water …………………………………. to 100 ml Menthol dissolves in eucalyptus oil. Light MgCO3 is a diffusing agent. Water is a vehicle. Grind the menthol to fine powder in a glass mortar, add eucalyptus oil, which dissolves menthol. Gradually add light MgCO3 to mortar & mix well, add water gradually to produce a pourable suspension. Rinse into a tared, amber ribbed bottle and make up the volume. LabelDIPLOMA 07/13/2024 & dispense. IN PHARMACY MDPH 2502 7  Method of Preparation Menthol & Eucalyptus Inhalation BP 1980 Formula: Menthol………………………….…….. 2 g Eucalyptus oil……………………........ 10 ml Light Magnesium Carbonate………… 7 g Water …………………………………. to 100 ml Menthol dissolves in eucalyptus oil. Light MgCO3 is a diffusing agent. Water is a vehicle. Grind the menthol to fine powder in a glass mortar, add eucalyptus oil, which dissolves menthol. Gradually add light MgCO3 to mortar & mix well, add water gradually to produce a pourable suspension. Rinse into a tared, amber ribbed bottle and make up the volume. LabelDIPLOMA 07/13/2024 & dispense. IN PHARMACY MDPH 8 2502  Labeling and Container Dispensed in white fluted bottles. Direction to shake the bottle before use. DIPLOMA IN PHARMACY MDPH 07/13/2024 9 2502  Aerosol Inhalations Consists of a solution or suspension of a medicament in a mixture of inert propellants which is held under pressure in an aerosol dispenser, consists of a suitable container fitted with a special metering valve. DIPLOMA IN PHARMACY MDPH 07/13/2024 10 2502  Definition Inahalation Preparation are liquid or solid dosage forms intended for administration as vapours or aerosols to the lung in order to obtain a local or systemic effect. They contain solution or dispersion of one or more active ingredients which may be dissolved or dispersed in a suitable vehicle. Inhalation preparation intended to be administered as aerosol (dispersion of solid or liquid particles of active ingredient in a gas) are administered by pressurized metered – dose inhaler or by powder inhalers. Pressurised Metered Dose inhalers are dosage form containing therapeutically active ingredients that are packed under pressure in a sealed container and are released as a DIPLOMA 07/13/2024 fine INmist ofMDPH PHARMACY spray up on actuation 11 2502 There are two types of Pressurized Metered Dose Inhalers 1. Two phase system consisting of gas and liquid 2. Three phase system consisting of gas, liquid and solid or liquids. STANDARD TESTS OR EVALUATION Pressurised Metered – Dose Preparation 1) Description: It should comply with Specification of Products. 2) Content of active ingredient delivered per actuation: Shall Comply with the specification. 3) Uniformity of delivered dose : The preparation complies with the test if 9 out of 10 results lie between 75 to 125 % of the average value and all lie between 65 to 135%. If 2 or 3 values lies out side the limits of 75 – 125 %. Repeat the tests for two more inhalers. Not more than 3 of 30 values lie out side the limitsDIPLOMA of 65IN –PHARMACY 135 %. MDPH 07/13/2024 12 2502  4) Particle size : The number of pariticles longer than 20 micron meter dosen’t exceed 50 and no particles exceeds 100 micron meter in length. 5) Number of deliveries per containers: The number of deliveries so discharged in the test for particles size is not less than the number stated on label. 6) Deposition of emitted dose: as per IP or the specification. 7) Leak Test: A average leakage rate of the 12 containers should not more than 3.5 % of the net fill weigh per container and none of the containers leaks more than 5 % of the net fill weight per year. DIPLOMA IN PHARMACY MDPH 07/13/2024 13 2502  Labeling and Container Supplied in containers of metal or of glass protected with a plastic coating. Labeling: - Name of the preparation, - The amount of the active ingredients in each valve is actuated. DIPLOMA IN PHARMACY MDPH 07/13/2024 14 2502  Types of Inhalation Devices Three basic types of devices used to deliver inhaled medication: 1. Metered dose inhaler (MDI), which use chemical propellant to push the medication out of the inhaler. DIPLOMA IN PHARMACY MDPH 07/13/2024 15 2502  2. Nebulizers, deliver fine liquid mists of medication through a tube or a mask that fits over the nose and mouth, using air or oxygen under 3. pressure. Rotary inhalers and other dry powder inhalers deliver medication without using chemical propellants. DIPLOMA IN PHARMACY MDPH 07/13/2024 16 2502  Ear Drops (Otic Solutions) The preparations intended for instillation in the outer ear. Otic drugs may be formulated as solutions or suspension. The vehicle may be water, glycerin, or a co-solvent system containing water and alcohol. DIPLOMA IN PHARMACY MDPH 07/13/2024 17 2502  Ear Drops Otic solutions may also contain additives such as preservatives, antioxidants, viscosity increasing agents or surfactants. Alcohol may cause stinging, ensure the patient is aware of this, if unacceptable change to aqueous based ear drops. Oils such as almond or olive are often recommended for alleviation of impacted ear wax, usually suggested to warm the oil before use, this must be done very carefully, excessive heat will have serious consequences for the integrity of the ear. DIPLOMA IN PHARMACY MDPH 07/13/2024 18 2502  Packaging/Storage/Labeling BP – ear drops should be supplied in coloured fluted glass bottles fitted with a plastic screw cap incorporating a glass dropper tube fitted with a rubber teat, or in plastic squeeze bottles fitted with a plastic cap incorporating a dropper device. Manufacturers usually supply in small glass or plastic containers with a dropper. Should be labeled “For External Use Only”. DIPLOMA IN PHARMACY MDPH 07/13/2024 19 2502  Ear Drops Chloramphenicol Ear Drops Concentration if not specified, 5% to be dispensed Hydrocotisone & Neomycin Ear drops Hydrocortisone acetate is insoluble in water Neomycin sulphate is soluble in water if not specified: Hydrocortisone acetate 1.5% w/v Neomycin Sulphate 0.5% w/v preparation is a suspension. Sodium bicarbonate ear drops Sodium bicarbonate……………..5 g Glycerin……………………………30 ml Water freshly boiled & cooled…..to 100 ml Dissolve 5 g of sodium bicarbonate in approximately 60 ml of water add glycerin & water to produce the required volume. DIPLOMA IN PHARMACY MDPH 07/13/2024 20 2502  Nasal Formulations Drugs are administered into the nostrils by the nasal route. Solutions may be nasally administered as sprays or drops. This route enables conditions of the nose, such as nasal congestion or allergic rhinitis, to be treated without administering the drug systemically. DIPLOMA IN PHARMACY MDPH 07/13/2024 21 2502  Nasal Formulations They may be aqueous or oily solutions and usually contain substances with antiseptic, local analgesic or vasoconstrictor properties. The surface of the nasal cavity is large, has a rich blood supply, and can hold about 20 ml. Most nasal formulations are used for their decongestant activity on the nasal mucosa. Nasal absorption of some drugs could result in blood concentrations close to IV administration. Nasal formulations are solutions, suspensions, (sprays, drops), gels. DIPLOMA IN PHARMACY MDPH 07/13/2024 22 2502  Nasal Formulations The vehicle for nasal solutions is usually water, but it may be a co-solvent system. Oily nasal drops should not be used over long periods, as the oil retards the ciliary action of nasal mucosa. Drops of oil may enter the trachea and cause Lipoid Pneumonia. Nasal solutions may also contain preservatives, buffers, antioxidants, surfactants and tonicity adjusting additives. Nasal solutions should be as close to isotonic as possible – cilia in nasal passages are sensitive to osmotic pressure. DIPLOMA IN PHARMACY MDPH 07/13/2024 23 2502  Packaging/Storage and Labeling Nasal drops should be supplied in colored fluted glass bottles fitted with a plastic screw cap incorporating a glass dropper tube fitted with a rubber teat or, in a plastic squeeze bottle fitted with a plastic cap incorporating a dropper device. Labeling: Shake the bottle before use For external use only DIPLOMA IN PHARMACY MDPH 07/13/2024 24 2502  THANK YOU DIPLOMA IN PHARMACY MDPH 07/13/2024 25 2502