Mpanyane T 201903234 EXPERIMENT 1 PHA3402 Experiment NO:1 AIM: To prepare and send 100ml of Diphenhydramine Hydrochloride Solution Formula: Ingredients Master Formula Diphenhydramine hydrochloride 250 mg Calculated amount 250 mg Glycerin 5ml Simple syrup 30 ml 30 ml Vanillin solution 0.067%w/v 0.2 ml 0.2 ml Distilled water 100 ml to 5 ml to 100 ml Method of preparation The apparatus used were first cleaned and the amber bottle tarred to 100ml. Then 20.0g sucrose was weighed using a balance then transferred to a beaker and purified water was added to a volume of 30 ml then the stirred using a rod to make simple syrup. Vanillin of 0.00027g was weighed then transferred into a measuring cylinder before purified water was added until a volume of 0.4 ml. A balance was then used to weigh 250 mg of diphenhydramine hydrochloride which was transferred into a beaker. Glycerin of about 5 ml was measured using a measuring cylinder and then transferred into a beaker and 0.2 ml of vanillin solution of 0.067%w/ was transferred using a micro-pipette. In the same beaker, 30 ml simple syrup was added and measured using a measuring cylinder. Water that was less than 20ml was added into the beaker containing the four ingredients then a stirring rod was used to stir until solution formed then that solution was transferred into a calibrated bottle then more distilled water was added to a volume of 100 ml and the bottle was shaken until all ingredients had dissolved. Ingredients used and their functions Glycerine – solvent Simple syrup- sweetener Diphenhydramine hydrochloric Active Pharmaceutical ingredient Vanillin solution 0.067%w/v- flavouring agent Distilled water- vehicle Indication and precautions Used to relieve cough May cause drowsiness Keep out of reach of children Store below 25 °C and away from direct light Label 100 ml Diphenhydramine Hydrochloride solutions 12.5 mg 5 ml Take 5ml twice a day Store below and away from direct sunlight May cause drowsiness Keep out of reach of children Batch DOM: Expiry date Name: Dispensed on 208 P 19/10/2020 18/10/2022 T.Mpanyane 15/01/2022 NUL Pharmacy. Roma Box 180 Calculations Multiplying factor= amount required/total amount of master formula=100ml / 100ml= 1 Diphenhydramine Hydrochloride 250mg × 1= 250mg Glycerine 5ml × 1 = 5ml Simple syrup 30ml × 1= 30ml Sucrose 66.7 × 30ml = 20.01g Vanillin solution 0.2ml × 1 = 0.2ml Vanillin solution 0.067w/v % 0.067 × 0.2ml = 0.000134g Strength 250𝑚𝑔 ×5ml = 100𝑚𝑙 12.5mg/5ml Percentage strength is therefore 12.5mg/5ml Answers to questions 1. Quality attributes of pharmaceutical solutions The appearance of the pharmaceutical solution should be appealing to the eye. The solution has to be palatable. The correct dose of drug should be used during preparation of the pharmaceutical solution. The solution has to be free from microbes. The solution should be both chemically and physically stable throughout its shelf life. 2. Advantages of pharmaceutical solutions Solution provide dose uniformity. Oral Solutions can easily be swallowed so can beneficial for patients with swallowing difficulties such as children and older people. In a solution, the drug is already dissolved in the solvent system therefore drug action can be rapid which then makes solutions a favourable option in medical emergencies. In such cases where drug absorption is required before drug action, the drug in a solution is already in a molecular form and thus, available for absorption. Disadvantages of pharmaceutical solutions Many drugs are poorly soluble in water which makes formulating them as solutions rather challenging. Solutions require an accurate spoon or syringe to measure the dose. Since solutions are liquids, they are bulky and make it difficult for the patient to carry. Some drugs are inherently unstable, and this instability is increases when a drug is present in a solution. 3. Classes of excipients and their examples Co- solvent: Ethanol Viscosity enhancers: Polyvinyl alcohol Flavouring agents: raspberry Antimicrobial preservatives: chlorobutanol Antioxidants: sodium sulphate Chelating agents: disodium edentate pH adjusters: sodium hydroxide Isotonicity adjusters: sodium chloride Sweeteners: sucrose
