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1 Compounding Resources s Dr Abbas Pardakhty 2011 Kerman Faculty of Pharmacy ١ ٢ Compounding - Contemporaryمعاصر - Extemporaneousفي البداهه ٣ ٤ ٥ ٦ ١

2 M ethod of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each i ngredient. Combine the glyceryl stearate, cetyl a lcohol, petrolatum, and mineral oil, and heat t he mixture to about 6 0 C to 7 0 C. Dissolve the u rea in about 4 0 m L of purified wate r. Mix the t erbinafine, Carbopol 9 4 0, and xanthan gum w ith the propylene glyco l. Incorporate the propylene glycol solution into the urea solution ; m ix well and heat to about 6 0 C to 7 0 C. C ombine the two mixtures and mix whil e agitating to form an emulsion. Add th e trolamine; while the mixture is cooling, add sufficient purified water to final weight and mix well. Package and label. ٧ ٨ U se: This preparation has been used in the treatment of fungal infections. Packaging: Package in tight, light- resistant containers. L abeling: For external use only. Keep out of the reach of children. Discard after [time period]. Stability: A beyond- u se date of up to 30 d ays may be used for this preparation. 1 Quality Control: Quality- control assessment can include theoretical weight compared with actual weight, specific gravity (SG), active drug assay, color, texture-surface, texture- spatula spread, appearance, feel, rheologic properties, and physical observations. ٩ ١٠ ١١ ١٢ ٢

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5 ٢٥ ٢٦ ٢٧ ٢٨ R x P soriasis Lotion ( 100 m L) C oal tar solution 5 S alicylic acid 5 g U rea 10 g Triamcinolone a cetonide 160 mg P ropylene glycol qs D issolve the urea and salicylic acid in about 75 m L of p ropylene glycol; this may take 30 t o 45 minutes. Add the triamcinolone a cetonide a nd mix well. Incorporate the coal t ar solution and mix w ell. Add sufficient propylene glycol to m ake 100 m L and thoroughly mix. Package and label. C oal tar Solution: coal tar 20%, p olysorbate 80 5 %, in alcohol ( 96%), ٢٩ ٣٠ ۵

6 Ingredients Purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, and flavoring. Buffered with citric acid and sodium citrate. Preserved with methylparaben ( 0. 03%), propylparaben ( %), and potassium sorbate ( 0.1 %). ٣١ ٣٢ B ody Weight (kg) Body Weight (lbs) 16 < 15 kg < 33 lbs t o 23 k g 34 t o 51 l bs Total Volume to Compound per patient () Total Volume of Compounded Oral Suspension needed to be Prepared 30 m L 40 m L 50 m L 60 Required number of 6 c apsules ( c apsules ( c apsules ( c apsules ( 900 T AMIFLU 75 mg Capsules mg oseltamivir) mg oseltamivir) mg oseltamivir) mg oseltamivir) Required volume of vehicle 24 t o 40 k g 52 t o 88 l bs > 41 kg > 89 lbs Cherry Syrup (Humco) OR Ora-Sweet SF (Paddock Laboratories) m L 48 m L 57 ٣٣ ٣٤ Carefully separate the capsule body and cap and transfer the contents of the required number of T AMIFLU 75 mg Capsules into a clean mortar. Triturate the granules to a fine powder. Add one- third ( 1/3 ) of the specified amount of vehicle and triturate the powder until a uniform suspension is achieved. Transfer the suspension to an amber glass or amber p olyethyleneterephthalat e ( PET) bottle. A funnel may be used to eliminate any spillage. Add another one- third ( 1/3 ) of the vehicle to the mortar, rinse the pestle and mortar by a triturating motion and transfer the vehicle into the bottle. Repeat the rinsing (Step 5 ) with the remainder of ٣٥ the vehicle. Shake well to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved d rug in the resulting suspension. (Note: The active drug, o seltamivir p hosphate, readily dissolves in the specified vehicles. The suspension is caused by some of the inert ingredients of TAMIFLU Capsules which are insoluble in these vehicles.) Put an ancillary label on the bottle indicating "Shake Gently Before Use". [This compounded suspension should be gently shaken prior to administration to minimize the tendency for air entrapment, particularly with the Ora- Sweet SF preparation.] Instruct the parent or guardian that any remaining material following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label ٣٦ instructions. Place an appropriate expiration date label according to ۶

7 STORAGE OF THE PHARMACY- COMPOUNDED SUSPENSION: R efrigeration: S table for 5 w eeks ( 35 days) when stored in a refrigerator at 2 to 8 C ( 36 to 46 F). R oom Temperature: S table for five days ( 5 days) when stored at room temperature, 25 C ( 77 F). Solubility of the pharmaceuticals ٣٧ ٣٨ Official solubility v ery soluble: 1 i n less than 1 f reely soluble: 1 i n 1 t o 1 i n 10 s oluble: 1 i n 10 t o 1 i n 30 s paringly soluble: 1 i n 30 t o 1 i n 100 s lightly soluble: 1 i n 100 t o 1 i n 1000 v ery slightly soluble: 1 i n 1000 t o 1 in p ractically insoluble: 1 in more than ٣٩ ٤٠ S olubility of Glycolic acid: Easily soluble in cold water. Soluble in methanol, diethyl ether, acetone. Solubility: Partially soluble in cold water. S olubility in water: 1 g /l at 1 C; 2. 4 g /l at 20 C.; 8. 2 g/l a t 50 C ; 22 g /l at 65 C. Alcohol: Freely Soluble Ether: Very Soluble Freely soluble in boiling water Warning - Pregnant women or those who may become pregnant should not be exposed to this chemical ٤١ ٤٢ ٧

8 Clindamycin phosphate 1 in 2. 5 water S olubility: Soluble in cold water, hot water, methanol, ethanol, glycerin and diethyl ether. ٤٣ ٤٤ Kojic acid Soluble in water and alcohol. Alcohol and PG ٤٥ ٤٦ Alcohol & PG 1 i n 3 alcohol 1 i n 15 boiling water 1 i n 10 castor oil ٤٧ ٤٨ ٨

9 Sulfurated potash PABA A mixture of potassium polysulfides, sulfite and thiosulfite. 1 i n 2 water Freely soluble in ethanol. ٤٩ ٥٠ Urea ٥١ 1 in 1. 5 water 1 i n 10 alcohol E rythromycin base: 1 m g per 1 ml of water. e stolate (erythromycin propionate l auryl sulfate): practically insoluble in water. e thylsuccinate: slightly soluble in water. l actobionate: freely soluble in water. g luceptate: freely soluble in water. ٥٢ Dioxybenzone, 8-Benzophenone E rythromycin base: soluble in alcohol. e stolate (erythromycin propionate l auryl sulfate): soluble in alcohol ( 50 m g per 1 ml alcohol). e thylsuccinate: freely soluble in alcohol. l actobionate: freely soluble in alcohol. g luceptate: freely soluble in alcohol. ٥٣ ٥٤ Alcohol Toluene ٩

10 Dithranol, Anthralin Resorcinol Fixed oils Acetone Chloroform 1 i n less than 1 i n 1 water 1 alcohol ٥٥ ٥٦ Formulations Azelaic acid cream 20% Azelaic acid 20g elt and S tearic mix lipid acid phase at 9g D issolve aq. Phase at 75 C C etyl alcohol 10 g W hite soft paraffin 4g Propylene glycol 8g Triethanolamine 2g Methyl parabene 0. 18g Propyl parabene 0. 02g Purified water to 100g M 70 C ٥٧ ٥٨ Azelaic acid cream Aminobenzoin acid lotion Azelaic acid 10-20g Purified water 40ml Eucerin to 100g Dissolve Azelaic acid in 85 C water. Add and mix gradually with Eucerin PABA 5g Glycerol 20ml A lcohol 60 ml Freshly boiled and cooled water to 100ml Dissolve PABA in alcohol, add glycerin then water. ٥٩ ٦٠ ١٠

11 ٦١ and Zinc acetate lotion Zinc acetate 1.2g PG 10ml Alcohol 70% to 100ml Dissolve in 67.5 ml Alcohol 96 and add PG. Dissolve Zinc acetate in water and mix. 4g ٦٢ Aluminium acetate solution (Burow s solution) Aluminium sulfate 22.5g Acetc acid ( 33% ) 25ml Calcium carbonate 10g Water 75ml Tartaric acid 4.5g 6 ml warm water and cool to RT. Dissolve Al2( SO4) 3 in 0 Add acetic acid. Disperse calcium carbonate in water to form a suspension. Mix two phases and store in a cool place for 24 h. Filter it and add tataric acid and store at cool place. Acetic acid ear drop Acetic acid ( 33% ) 3ml Freshly boiled and cooled water to 100ml Compound benzoic acid ointment Whitefield s ointment Benzoic acid Salicylic acid (B.P.), Emulsifying ointment to 100g 6g 3g Levigate the powders in liquid paraffin and add geometrically to emuls. oint. ٦٣ ٦٤ Shohl s solution Kojic acid cream Citric acid monohydrate 14g Sodium citrate 9.8g Water to 100ml Used for Nephritic tubular acidosis. Citric acid 12.8g Sodium citrate 9.8g Water to 100ml Kojic acid 3g Purified water 20ml Dissolve kojic acid in water. Add and mix gradually with Eucerin. Eucerin to 100g ٦٥ ٦٦ ١١