Manuf Notes- Prep 4, 5, 6

EGR

MANUF LAB (PRELIMS) PREPARATION 4,5,6 POWDERS  mixture of finely divided drugs &/or chemicals in drug form  may be finely subdivided, coarsely comminuted product or product of intermediate particle size  used internally or externally Advantages:  flexibility of compounding  good chemical stability  rapid dispersion of ingredients Disadvantages  Time consuming  inaccuracy of dose  unsuitability for many unpleasant tasting, hygroscopic and deliquescent drugs Packaging & Dispensing  Bulk Powder  Divided Powder

Sieve Size: All Particles Pass Through

Very Coarse (No. 8)

20

Coarse (No.20)

20

Moderately (No.40)

Coarse

USP Descriptive Terms

Sieve Size: All Particles Pass Through

20

Coarse (No.20) Moderately (No.40)

Coarse

40

Fineness Nmt 60% through a no.40 sieve Nmt 60% through a no.60 sieve

Fine (No.180)

180

No Limit

Very Fine (No.120)

120

No limit

Manufacturing Procedures  Triturate  Weigh  Blend  Sieve  Blend  Tumble  Pack  Weigh PREPARATION 4: Oral Rehydration Salts

Characteristics  Homogenously blended Methods of Blending a.) Small Scale Spatulation Trituration Geometric dilution Sifting b) Large Scale Tumbling  Must be of the most advantageous particle size Comminution techniques a) Small Scale Trituration Levigation Pulverization by intervention b) Large Scale Various mills Pulverizers USP Standards for Powders of Animal & Vegetable drugs USP Descriptive Terms

USP Standards for Powder of Chemicals

40

Fine (No.60)

60

Very Fine (No.80)

80

NaCl......................................... 1.6 g KCl............................................ 1.5 g ` NaHCO3................................... 1.5 g Anhydrous Glucose............. 36.4 g For 1 L soln *Each subgroup prepared for 200 mL soln Guidelines in labeling  Electrolytes for ORT must be expressed in mEq  Quantities of electrolytes administered to patients  Prep of Label ORAL REHYDRATION SALTS Provides 200 mL Soln Sodium.................................................... ___meq Potassium.............................................. ___meq Chloride................................................. ___meq Bicarbonate........................................... ___meq Anhydrous Glucose............................ ___meq

Fineness



Not more than (nmt) 20% through a no.60 sieve



Nmt 40% through a no.80 sieve Nmt 40% through a no.80 sieve Nmt 40% through a no.100 sieve No limit to greater fineness



Direction for reconstitution must be indicated in the labelling materials Dispensing: Each dose should be dissolved in sufficient, freshly boiled and cooled water to make 200 mL solution taking hygiene and precaution. Storage: Powders: ______________ After reconstitution: Unused soln must be discarded after 1 hour Refrigerated: may be kept for 12 - 24 hrs

2 SUSPENSION  Preparation containing finely divided drug particles distributed uniformly throughout a vehicle  2 phase systems  dispersed medium can be oily or aqueous  dispersed phase is usually greater than 0.5 Preparation = GELOMAMI Purpose: Sustaining Effect Stability Taste Base Solubility Properties of Ideal Suspension  uniform particle size  no particle interaction  no sedimentation or slow sedimentation rate  other properties: redisposable, chemically stable, acceptable to consume Components  Active Ingredient  Wetting Agt -make them more soluble to solvent -Alcohol, PPG, Sorbitol, Surfactant  Floculating Agt -avoid aggregates -electrolytes < 1% of KCl & NaCl  Viscosity Agt -increases viscosity, hydrophillic colloids -clays, gums  Buffer  Preservative  Flavorant  Colorant  Solvent 2 Forms of Suspension  Ready to use - oral suspension - no reconstitution needed  Dry Powders/ Dry Granules for Oral Suspension -reconstitution required -contains "for oral suspension" PREPARATION 5: Aluminum Magnesium Hydroxide Al(OH)3......................................................7% (Active Ing) Mg(OH)2....................................................3% (Active Ing) CMC Na....................................................2.5 % (Viscosity Agt) Peppermint................................................0.1% (Flavorant) Na Saccharin..............................................0.1% (Sweetener) Na Benzoate...............................................0.1% (Preservative) Sorbitol Soln...............................................20% (Wetting Agt) Purified H2O qs ad.....................................100%

Procedures:  Place Mg(OH)2 in a blender  Add Sorbitol Soln  Add purified water (1/3)  Blend the mixture 5 mins  Add Al(OH)3 gel blend for 5 mins  Place CMC in a mortar & triturate with 50 mL water until paste is formed  Add CMC paste to the blender  In a separate container, heat water to 500C & dissolve saccharin solution & Sodium benzoate. Cool the soln to 400C. Charge into blender & blend for 10 mins  Add Peppermint oil  Homogenize the suspension  QS H2O. Blend for 1-2 mins GRANULES  Prepared agglomerates of smaller particles  Irregularly shaped and behave as single larger particles  uses sieve #4 -12 for particles size classification Granulation  Pharmaceutical process that attempts to convert produced materials into aggregates Large Scale - granulating machine on granulation Small Scale powder + water => moist mass =>sieve #4-12 =>net granules =>(drying) Dry granules Advantages  flow well composed to powder  more stable physically and chemically than powders  Easily wetted PREPARATION 6: Phenoxymethyl Penicillin Phenoxymethyl Penicillin............................ 25g CMC................................................................ 25g Sucrose............................................................125g Na benzoate...................................................9 g Citric Acid......................................................5g Cone strawberry powder ..........................1g Lactose...........................................................30g

EGR

3 Procedures:  Mix the powders & blend for 15 mins using titration  Prepare 20 mL colorant solution & spray into powder mixtures with continuous trituration until a moist mass is formed  Pass the moist mass through sieves #12 & receive net granules in a tray  Oven dry granules a temp not exceeding 400C -1 hour  Dry the granules until 1 nmt 2% moisture is present. Check the moisture content every 30 mins weigh & pack the divided granules

EGR