The Pharmaceutics and Compounding Laboratory
Powders and Granules

Laboratory Procedure

A. Preparation of Divided Powder

1. Compound and dispense the following prescription.

 

                 The University of North Carolina     Rx# 61601
                         School of Pharmacy
                         Chapel Hill, NC
Phone:  555-1234                                 DEA# PS0079411

Name:  Pete E. Arick, Jr. (age 11 months)       Date:   Today  
Address:  300 Graham St., Chapel Hill, NC 27599 Phone:  911-1234

  Rx
               Salicylic Acid   30 mg
               Lactose q.s.    250 mg
               M.Ft. chart DTD #10
               Sig: 1 Chart in juice q 4h prn T > 99.5

  No Refills

  Angela Murcee, M.D.                                        
  Dispense as written             Product selection permitted

Procedure:

Using geometric dilution, triturate the components in a mortar and prepare 10 powder charts (making calculations for 12 charts). Dispense 6 charts and save 4 for subsequent testing.

Video View a video demonstration on geometric dilution

2. Evaluation of Divided Powders

Empty the contents of each of the 4 reserved charts into 4 Erlenmeyer flasks. Add 100 ml of 0.01 N NaOH to each flask and stir to effect dissolution. Determine the absorbance of each sample at 325 nm on a spectrophotometer. Prepare a blank of 0.01 N NaOH.

Using a set of reference standards of known concentration, prepare a Beer's Law plot (absorbance vs. concentration). Using this Beer's Law data, calculate the amount of drug in each chart, and calculate the mean, standard deviation and relative standard deviation of your results.

B. Preparation of Effervescent Granulation

1. Compound and dispense the following prescription.

 

                 The University of North Carolina        Rx# 61602
                         School of Pharmacy
                         Chapel Hill, NC
Phone:  555-1234                                      DEA# PS0079411

Name:  Ben D. Rools                                 Date:   Today  
Address:  112 N. Church St., Chapel Hill, NC 27599  Phone:  654-3211

  Rx
                 Aspirin                 gr. 80
                 Sodium Bicarbonate      gr. 220
                 Tartaric Acid           gr. 120
                 Citric Acid Monohydrate gr. 80
                 M.Ft. granules
                 Sig: 1 tsp q 6h prn pain
  2 Refills

  Mel Praktisute, M.D.                                     
  Dispense as written          Product selection permitted

Procedure:

Mix all components using geometric dilution. Pass the powder mass through a 40-60 mesh sieve. Package in dry, airtight container.

C. Preparation of Dusting Powder

1. Compound and dispense the following prescription.

                 The University of North Carolina        Rx# 61603
                         School of Pharmacy
                         Chapel Hill, NC
Phone:  555-1234                                        DEA# PS0079411

Name:  Wendy Wenbloes                                 Date:   Today  
Address:  118 Summerbreeze Dr, Chapel Hill, NC 27599  Phone:  667-1110

  Rx
               Calamine              15%
               Magnesium Stearate     1%
               Talc q.s.             50 g
               M.Ft. pulv
               Sig: Dust affected area t.i.d.

  No Refills

  Lee Keybote, M.D.                                          
  Dispense as written             Product selection permitted

Procedure:

Using geometric dilution, triturate the components in a mortar. Pass the powder mass through a 100-200 mesh sieve.

Video View a video demonstration on how to sieve a powder

Transfer carefully into a sifter top container. (If sifter top container unavailable, use wide mouth jar and provide patient with instructions for administering the powder). Avoid inhaling the dust.


I. Prelab data

Preparation of Divided Powder (Rx #61601)

Compounding Formula for Twelve Charts:

Salicylic Acid_____________ mg
Lactose_____________ mg
Total Weight of 12 Charts_____________ mg
Weight of Each Chart_____________ mg

Preparation of Effervescent Granulation (Rx #61602)

Compounding Formula:

Aspirin______________ g
Sodium Bicarbonate______________ g
Tartaric Acid______________ g
Citric Acid Monohydrate______________ g
Total Weight of Granulation______________ g

Preparation of Dusting Powder (Rx# 61603)

Compounding Formula:

Calamine______________ g
Magnesium Stearate______________ g
Talc______________ g
Total Weight of Powder______________ g

II. Experimental Data and Results

A. Divided Powders

  • Inspection of Final Product ______________________
  • Evaluation of Divided Powders
    • Prepare a Beer's Law plot and show the slope, intercept, and R2 values. Attach graph.
    SA Standard Absorbance @ 325 nm Regression Analysis
    0.4 mg/ml _______________ intercept = _______
    0.3 mg/ml _______________  
    0.2 mg/ml _______________ slope = __________
    0.1 mg/ml _______________  
    0.0 mg/ml _______________ R2 = ____________

    b. Complete the following table:

    Sample Absorbance @ 325 nm Concentration Amount of Drug Per Chart
    1
     
     
     
    2
     
     
     
    3
     
     
     
    4
     
     
     

    Average ____________________

    Standard Deviation ____________

    B. Granulation

      Inspection of Final Product ______________________

    C. Bulk Powder

      Inspection of Final Product ______________________

    III. Discussion

    1. Discuss the content uniformity of the powder charts you prepared. Is it within acceptable limits?

    2. How would you instruct a patient to take Rx #61602?

    3. If sodium carbonate is to be used instead of sodium bicarbonate in the preparation of effervescent granules, what would be the amount needed to neutralize three (3) gm of citric and tartaric acids in a ratio of 1:2 respectively?

    4. What is the role or purpose of each ingredient in the dusting powder you prepared?

         Calamine -

         Talc -

         Magnesium stearate -