Phardose Lab Prep 1-6

Kimberley Anne See 2A-Pharmacy | A.Y. 2015-2016 Preparation 1: Divided Powders EXPERIMENT: Category: powders Category: powders Ingredients: Ingredients: Levothyroxine Na (Eltroxin) 50 mcg Lactose Synonym: Synonym: Chartulae Method of preparation: block and divide Computations:

Packaging: glassine paper & paper envelope Label: white (internal) POST-LAB: Powders -mixture of finely divided solids or chemicals in a dry form -may be used internally or externally Bulk powders  -antacid, laxatives Divided powders  -individual doses -dispensed in papers Types of papers used: Vegetable parchment  -semi-opaque -moisture resistant -most preferred  White bond paper -opaque -not moisture resistant Glassine paper  -glazed; transparent -moisture resistant Waxed paper  -waterproof paper -transparent  Advantages: Flexibility of compounding   Good chemical stability Rapid dispersion of ingredients  Disadvantages:

Time consuming preparation  Inaccuracy of dose  Unsuitable for many unpleasant tasting, hydroscopic and deliquescent drugs Micromeritics -study of small particles Mixing -mechanical process of reducing solid particle size of solids (COMMINUTION) Different mixing techniques: Spatulation  -use of spatula (on a tile/paper) -used for EUTECTIC (powders that liquefy; low melting points) MIXTURES -not applicable for large scale  Trituration -mixing and reducing -use of mortar and pestle Wooden — fibrous; fibrous; comminution of o crystalline solids Glass — non-staining; non-staining; nonporous; o flavoring oils; colored substances Porcelain — commonly commonly used, grazed, less o porous Geometric Dilution  -for mixing POTENT SUBSTANCES -Quinine sulfate  Sifting -light blocky, dense powder -sifter is used Tumbling  -mix large amount of powder -use of tumbler; 2/3 of volume  Advantages  Increases surface area (increase dissolution and bioavailability)  Increase extraction or reactivity re activity Facilitates hot drying of masses   Improves blending and mixing Uniform distribution of coloring agents  Improve texture, appearance and physical  stability Disadvantages Can change the polymorphic form of the  active ingredients  Degrades the drug Decrease bulk density  

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Kimberley Anne See 2A-Pharmacy | A.Y. 2015-2016 Decrease the particle size (cause aggregation and decrease dissolution)  Increase surface area (promote air absorption and inhibits wettability) Different comminution techniques: 1. Large scale — use of mills, pulverizers 2. Small scale Trituration   Pulverization by intervention — reduce particle size with aid of a volatile solvent Levigation — form a paste (use of mineral oil,  glycerin)  Method for determination of particle size: 1. Sieving 2. Microscopy [1/3] 3. Sedimentation rate [2/3] — use Stoke’s law 4. Light energy diffraction/light scattering 5. Laser holography 6. Cascade impaction USP Standards for Powders of Animal and Vegetable Drugs 

Type of Powder

Very coarse

Sieve size all particles pass thru #20

Coarse

#20

Moderately coarse Fine

#40

Very fine

#80

#60

Sieve size % particles pass thru nmt 20% thru #60 sieve nmt 40% thru #60 sieve nmt 40% thru #80 sieve nmt 40% thru #100 sieve no limit

USP Standards for Powders of Chemicals Type of Powder

Coarse Moderately coarse Fine Very fine

Sieve size all particles pass thru #20 #40 #80 #120

Sieve size % particles pass thru nmt 60% thru #40 sieve nmt 60% thru #60 sieve no limit no limit

Preparation #2: Effervescent Granules EXPERIMENT: Category: granules Synonym: Pulvis effervescens compasitus Ingredients:

Sodium bicarbonate — effervescence (release of CO2) Citric acid — hygroscopic (pasty) Tartaric acid — loses air when exposed to water Method of preparation: wet method (classic) Packaging: 30 mL wide-mouth amber bottle Label: White (internal), unofficial Computations:

POST LAB: Granules -prepared agglomerates of small particles of powder -irregularly shaped but may be spherical -uses 4-12 sieve size range  Methods of preparation: Wet method  1. Classic — moistening then passing thru sieve then oven drying 2. Fluid-bed process — Powder is placed in conical piece of equipment Dry method  1. Fusion method — passing thru roll compactor then granulating 2. Slugging — compression of powder into large slugs/tablet (8k-12k pounds_  Advantages over powders:  Flow well More stable   Less likely to harden upon standing  Easily wetted by liquid  Compressibility Preparation #4: Chocolate Base Ca Lozenges EXPERIMENT: Category: lozenges Synonym: Calx chocolate lausiae Ingredients: Calcium carbonate Corn oil Chocolate bar Method of preparation: fusion/molding method Packaging: aluminum foil, paper box

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Kimberley Anne See 2A-Pharmacy | A.Y. 2015-2016 Label: White (internal), unofficial Computations:

POST LAB Lozenges -solid dosage form intended to slowly dissolve in the mouth -bucally or sublingually for absorption -used for local effect Types:  Hard lozenges -made from syrups of sucrose and other sugars -moisture content: 0.5% to 1.5% -preparation is similar to candy making Soft lozenges  -flavored fatty base [chocolate, PEG base, sugar-acacia base] Chewable gummy gel lozenges  -glycerinated gummy gel base  Methods of preparation:  Hand-rolling -do not require special calculations and equipment -pill roller, broad bladed spatula -requires experience and special te chniques  Fusion/molding method -can be used for all types of lozenges -requires heat, mold, skills and calcs -must not be used for heat sensitive drugs Preparation #5: Aspirin capsules EXPERIMENT: Category: capsules Synonym: Acetylsalicylic acid (ASA) Ingredients: Aspirin powder Method of preparation: punch method Packaging: 15 mL wide mouth amber bottle Label: White (internal), official Computations:

POST LAB Capsules -solid dosage forms in w/c medicinal agents and/or inert substances are enclosed w/in a small shell of gelatin that may be hard or soft -shells are usually made of GELATIN or STARCH Types Hard gelatin capsules  -made up of gelatin, sugar, water -made opaque by adding titanium dioxide -body + cap -filled by PUNCH METHOD or FILLING MACHINES -moisture content: 13%-16%  Soft gelatin capsules -made up of gelatin -more pliable due to presence of glycerin, or sorbitol (plasticizers) -active ingredient suspended in vegetable oil, water miscible glycol (PEG 400 or PEG) 000 15 gr 00 10 gr 0 7.5 gr 1 5 gr 2 4 gr 3 3 gr 4 2 gr 5 1 gr Preparation #6: Glycerin Suppositories EXPERIMENT: Category: Suppository Synonym: Suppositoria glycerin Ingredients: glycerin sodium stereate water Method of preparation: molding/fusion Packaging: suppository bottle Label: red (external), unofficial Computations:

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Kimberley Anne See 2A-Pharmacy | A.Y. 2015-2016 Computations:

POST LAB Suppositories -solid dosage forms intended for insertion into body orifices -localized/systemic effect Types: 1. Rectal suppositories -cylindrical/bullet shaped -32 mm (1.5 in) in length -2g adult -1g children 2. Urethral suppositories [Bougies] -slender or pencil shape Male: 140 mm long; 3-6 mm in diameter; 2g Female: 70 mm long; 1g Uses: erectile dysfunction, dilation of uterus, antiinfective agent 3. Vaginal suppositories [Pessaries] -globular, oviform, cone shaped -weighs 5g Uses: anti-fungal, anti-infective, contraceptive  Methods of preparation: 1. Molding from melt/fusion 2. Compression 3. Hand rolling/ shaping — easiest Bases: 1. Cocoa butter/theobroma oil -most widely used 2. Witepsol bases -fatty acid chain between C12 and C18 3. Wecobee base -derived from coconut oil 4. Glycinerated gelatin -water soluble Preparation #7: Cold cream EXPERIMENT: Category: cream Synonym: Petrolatum rose water ointment Ingredients: spermaceti white wax mineral oil sodium borate Method of preparation: fusion method

POST LAB Creams -viscous liquid or semisolid emulsions containing one or more medicinal agents -easier to spread and remove than ointment Types: Oil in water  -vanishes on skin -Galen’s cerate (vanishing cream)  Water in oil -imparts oily feeling on skin -emollient cream or cold cream

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