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Information about NASAL DROPS

Published on March 6, 2014

Author: pharmareddy


NASAL DROPS: NASAL DROPS Presented By S.AKSHARA S.SHIVA KUMAR S.SAI KUMAR R .BHAVANA S.GOWTHAMI (Pharm.D First Year) Under the guidance of Mr. M. Srujan Kumar Reddy M.Pharm (Ph.D) Assistant Professor DEPARTMENT OF PHARMACEUTICS SAMSKRUTI COLLEGE OF PHARMACY HYDERABAD CONTENTS:: CONTENTS: INTRODUCTION MEDICAMENTS COMMENLY USED EXAMPLES FOR NASAL DROPS FORMULATION DISPENSING STORAGE LABEL LATIN TERM:NARISTILLAE : LATIN TERM:NARISTILLAE Nasal drops are aqueous preparations of drugs, intended for instillation into nostrils with the help of a dropper. They are generally used for their antiseptic, local analgesic or vasoconstriction properties. Medicaments commonly used are: : Medicaments commonly used are: Anti-inflammatory : corticosteroids, betamethasone. Sympathaomimetics :Ephedrine hydrochloride Decongestants :phenylephrine, oxymetazole,Tetrahydrozoline hydrochloride , oxymetazole hydrochloride PowerPoint Presentation:  Nasal drops are generally formulated to resemble the nasal secrection. Hence nasal drops should be isotonic and slightly buffered, to maintain pH 5.5 – 7.5 .The viscosity of nasal drops should be similar to the viscosity of the nasal secretions. Therefore viscosity of nasal drops is adjusted with the help of thickening agents like methylcellulose, hydroxypropyl methylcellulose For preparation of nasal drops, generally aqueous vehicles is used . oils are not preferred as vehicles, because oily drops inhibit the ciliary movement of the nasal mucosa and even causes lipoidal pneumonia (drops of oil enters the lungs). PowerPoint Presentation: Since the nasal drops is instilled in to nasal cavity , that will be in contact with mucous membrane of nose , it should be clarified by passing through sintered glass funnel. before making he final volume with water EXAMPLES FOR NASAL DROPS : Ephedrine hydrochloride nasal drops , Phenylephrine nasal drops , Oxymetazoline nasal drops , Betamethasone nasal drops. FORMULATION: FORMULATION METHOD OF PREPARATION : Simple solution method is employed for the preparation of nasal drops , because most of the drugs and additives used are water soluble. Ingredients type Examples 1.vehicles Purified water 2.for tonicity adjustment Sodium chloride, dextrose 3.buffer Phosphate buffer (pH -6.5) 4.preservatives Chlorobutonol(0.5%) , benzalkonium chloride (0.01 to 0.05%), Aromatic alcohols (0.5 to 0.9%) PowerPoint Presentation: DISPENSING: Nasal drops are generally dispensed in small (10-15 ml capacity) clear or ambered coloured bottle with a dropper fitted with rubber teat. But now a days, nasal drops are dispensed in small, fluted plastic containers made up of polyethylene with “built in droppers” (bottle previously sealed with dropper ).   PowerPoint Presentation: Nasal drops should be used with in month (four weeks) after opening the seal of the containers .if any unused amount of nasal drops is present , that should be discarded after one month , to avoid contamination from microorganisms , if it is stored for longer time .   STORAGE : Nasal drops should be stored in cool place. LABEL:: LABEL: Nasal drops should bear necessary requirements of liquid dosage forms .in addition ,it should contain auxilliary labels like, FOR EXTERNAL USE ONLY . USE ONLY IN THE NOSTRIL OR FOR NASAL USE ONLY. NUMBER OF DROPS TO BE ISTILLED PER SINGLE TIME DISCARD THE CONTAINER AFTER ONE MOUNTH OF THE OPENING OF SEAL (CONTAINERS). NOT FOR INJECTION. DONOT TOUCH THE TIP OF THE DROPPER . DO NOT DILUTE WITH WATER BEFORE USE KEEP AWAY FROM CHILDREN.   EXAMPLES:  EXAMPLES EPHEDRINE HYDROCHLORIDE NASAL DROPS B.P.C PHENYLEPHIRINE HYDROCHLORIDE NASAL DROPS EPHEDRINE HYDROCHLORIDE NASAL DROPSB.P.C : EPHEDRINE HYDROCHLORIDE NASAL DROPSB.P.C THEORY: In this preparation, ephedrine hydrochloride acts as nasal decongestant. Sodium chloride is used to make nasal drops isotonic with nasal secretion. Chlorbutol is used as preservative Salts like ephedrine hydrochloride and sodium chloride are soluble in water, but chlorbutol is a volatile substance and it dissolves very slowly, in presence of salts at room temperature. Hence it requires vigorous shaking, with maximum amount of water In order to achieve rapid dissolution, first chlorbutol is dissolved in hot water. During dissolving, conical flask should be stoppered to prevent the volatisation of chlorbutol . after cooling, other salts are dissolved and the solution should be passed through sintered glass funnel, before making the final volume with water. RX Ephedrine hydrochloride 0.1g Sodium chloride 0.1g Chlorbutol 0.1g Water……..q.s…… 20ml PROCEDURE : : PROCEDURE : Accurately weigh the chlorbutol and powder it . Select a small conical flask with suitable stopper. In conical flask, take ¾ th quantity of water and heat to 60°C without putting the stopper . Add chlorbutol to the hot water and quickly insert the stopper, prevent the volatsaition of chlorbutol and shake well, solution completes Allow the solution to cool (room temperature) and ephedrine hydrochloride and sodium chloride, dissolve them by stirring and filter the solution through sintered glass funnel or muslin cloth Transfer the filtrate to a measure and adjust the final volume with water PowerPoint Presentation: DISPENSING: Ephedrine hydrochloride is light sensitive, therefore transfer the solution to the amber coloured , small glass or plastic bottle 10-15 ml capacity, close it thoroughly with rubber closure, polish, label and supply with dropper DIRECTION: To be instilled into nostrils ,as directed   STORAGE : Store in a cool and dark place . AUXILLIARY LABEL: : AUXILLIARY LABEL: FOR EXTERNAL USE ONLY OR FOR NASAL USE ONLY NOT TO BE DILUTED WITH WATER BEFORE USE DO NOT TOUCH THE DROPPER TIP STORE IN A COOL AND DARK PLACE KEEP AWAY FROM CHILDREN USES: :  USES: Local application of ephedrine hydrochloride to the mucous membrane of the nose stimulates the vasoconstrictor sympathetic nerve endings, hence produces a balancing of the area and a reduction in nasal secretions (nasal congestions) . If the mucous surface is inflamed, ephedrine relieves symptoms of painful swelling . it also relieves allergic and vasomotor rhinitis and sinusitis, therefore ephedrine hydrochloride nasal drops is used as nasal decongestant PHENYLEPHRINE HYDROCHLORID NASAL DROPS :  PHENYLEPHRINE HYDROCHLORID NASAL DROPS RX Phenylephrine hydrochloride 1.7ml Sodium metabisulphite 2ml Sodium chloride 0.12g Chlorbutol 0.1g Propylene glycol 1ml Purified water…..q.s……………… 20ml THEORY: : THEORY: Phenylephrine hydrochloride is used as active drug, which acts as nasal decongestant. In this preparation salts like phenylephrine hydrochloride, sodium chloride and sodium metabisulphite are easily soluble in water .phenylephrine is very sensitive to light and atmospheric oxygen ,hence it undergoes oxidation .therefore, to prevent its oxidation , sodium metabisulphite is used as antioxident . Sodium chloride is used to adjust the isotonicity of the preparation and chlorbutol is used as a preservative . propylene glycol is used to give viscous nature to the drops and acts as cosolvent. In presence of the salts like phenylephrine hydrochloride, sodium chloride and sodium metabisulphite , chlorobutol is very slowly soluble in water.(at 60°C)and after cooling , the drug and other ingredients are dissolved, filter the final volume . PROCEDURE: : PROCEDURE: Accurately weigh the chlorbutol and finely powder it by trituration. Select a small conical flask with a suitable stopper. In conical flask take ¾ th quantity of water and heat to 60°C without closing stopper. Add chlorobutol to the hot water and quickly insert the stopper and shake until solution completes , to prevent the volatisation of chlorobutol and allow the solution to cool (room temperature) To the chlorobutol solution , incorporate phenylephrine hydrochloride ,sodium chloride , sodium metabisulphite , propylene glycol ,in a sequence and make solution Filter the solution through a muslin cloth or sintered glass funnel , to remove any foreign particles present or any undissolved ingredient if remaining Adjust the final volume by adding sufficient volume of water .   PowerPoint Presentation: DISPENSING: Phenylephrine is very sensitive to the atmospheric oxygen and light , hence it undergoes oxidation reaction . therefore transfer the solution to a light resistant or plastic bottle of 10- 15 ml capacity ,close it tightly ,label and supply with a dropper .   DIRECTION: To be instilled into nostrils ,as directed   STORAGE : Store in a cool and dark place . PowerPoint Presentation: AUXILLIARY LABEL: FOR EXTERNAL USE ONLY OR FOR NASAL USE ONLY NOT TO BE DILUTED WITH WATER BEFORE USE DO NOT TOUCH THE DROPPER TIP STORE IN A COOL AND DARK PLACE KEEP AWAY FROM CHILDREN   USES: Phenylephrine nasal drops is used as nasal decongestant. DISPENSING PHARMACY a practical manual : DISPENSING PHARMACY a practical manual by SANMATI B S KALPESH K MEHTA ANUSH GUPTA

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