Reconstitution of Powders/ Granules for Oral
Session 11: Reconstitution of Powders/ Granules for Oral
Preparations
Total Session Time: 60 minutes + 6 hours of Practices
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
10 minutes Presentation Definition of Powders/ Granules for Oral
2 Preparations
Brainstorming
10 minutes Presentation Reconstitution of Powders/Granules for Oral
3 Preparations
Buzzing
25 minutes Presentation Performing Reconstitution of Powders/Granules
4 Demonstration for Oral Preparations
5 05 minutes Presentation Key Points
6 05 minutes Presentation Evaluation
Session X: ———— -(Title)———————- 72
SESSION CONTENTS
STEP1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing
STEP 2: Define Powders/ Granules for Oral Preparations (10 minutes)
Activity: Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
which a drug powder has normally been mixed with other powdered excipients to
produce a final product.
o Therefore Powders for oral Preparations are mixtures of finely divided solids
intended for oral administration and comprise of the active ingredients plus
excipients (such as diluents, sweeteners, and dispersing agents) where necessary.
o They are usually mixed with water or other suitable liquid before administration.
aggregated to form larger particles sufficiently robust to withstand handling.
single, discrete powder particles) are processed to adhere to form larger multi-particle
entities.
Session X: ———— -(Title)———————- 73
STEP 3: Reconstitution of Powders/ Granules for Oral Preparations (10
Minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
liquid.
o Therefore medicine reconstitution refers to use the given directions, or recipe, on
a prescription label to mix the powder contained inside to a specific concentration
as indicated.
use different diluents so be sure to read the medication label or package insert correctly
so that you use the proper diluent and volume needed to reconstitute the medication.
o If the correct diluent is not used, the medication may clump or crystallize making
it unusable for administration
o Examples of common diluent used in reconstitution of oral powders/granules are,
purified water, syrup, normal saline (NS 0.9%), dextrose 5% in water (D5W).
specific volume of a final product with the required concentration varies between
formulations.
read manufacturer‟s instructions (package inset), so as to know exactly which diluent to
be used and the amount of diluent to be added in order to produce the required
concentration.
half) should be added to medication and then mixed. Once the medication as started to
dissolve, the second portion of diluent is added and mixed. Be sure the medication has
dissolved completely before administering to the patient.
Session X: ———— -(Title)———————- 74
Figure 11.2: Instruction for Reconstitution of Amoxicillin Oral Suspension
Session X: ———— -(Title)———————- 75
STEP 4: Performing Reconstitution of Powders/ Granules for Oral
Preparations (25minutes)
Activity: Demonstration (20 minutes)
DIVIDE students in small manageable groups.
PREPARE equipment and materials needed for demonstration
POSITION students so that everyone can see and hear
REVIEW steps of that skill with students using a checklist
REFER students to the checklist of reconstituting powders/granules for oral
preparation
DEMONSTRATE the procedure of reconstitution of Oral rehydrating Salts (O.R.S)
ALLOW one student from each group to do a return demonstration and let others comment on it
CLARIFY and SUMMARIZE by using the content below
INFORM the students that “every student will practice in the skills laboratory under supervision
until is competent”
life after reconstitution is short, instruct patient on how to reconstitute before using the
medication. Reconstitution of such product is done in a container separate from the
original package of the powders/granules.
for further reading
STEP 6: Key Points (5 minutes)
administration and comprise of the active ingredients plus excipients (such as diluents,
sweeteners, and dispersing agents) where necessary.
label to reconstitute the powder contained inside to a specific concentration as indicated
specific volume of a final product with the required concentration varies between
formulations
manufacturer‟s instructions (package inset), so as to know exactly which diluent to be
used and the amount of diluent to be added in order to produce the required concentration
Session X: ———— -(Title)———————- 76
STEP 7: Evaluation (5minutes)
STEP 8: Practice (6 hours)
supervision on the following.
Session X: ———— -(Title)———————- 77
References
Aulton, M. E., & Taylor, K. (2013). Aulton's pharmaceutics : the design and manufacture of
medicines (4th ed.). Edinburgh: Churchill Livingstone/Elsevier.
Pharmaceutical Society of Great Britain., & Pharmaceutical Society of Great Britain. Department
of Pharmaceutical Sciences. (1994). The Pharmaceutical Podex, Principles and Practice
of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical P.
Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011).
Tanzania Pharmaceutical Handbook (2nd ed.). Dar es salaam: School of Pharmaceutical
Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied
Health Sciences.
Remington, J. P. (2005). Remington, the science and practice of pharmacy (T. David Ed. 21st
ed.). Easton, Pa. London, UK: Mack Pub. Co. Pharmaceutical Press.
Session X: ———— -(Title)———————- 78
Handout 11.1: Powders and granules for oral administration
Oral powders are preparations consisting of solid, loose, dry particles of varying degrees
of fine particles size. They contain one or more active substances, with or without
excipients and, if necessary, approved coloring matter and flavoring. They are generally
administered in or with water or another suitable liquid, or they may also be swallowed
directly.
Effervescent powders are presented as single-dose or multi-dose preparations and
generally, in addition to drug, contains acid substances and carbonates or Hydrogen
carbonates which reacts rapidly and effervesce when the patient adds the powder to water
to produce a draught.
o Citric acid plus sodium bicarbonate is a common combination that releases
Carbon dioxide, the drug is quickly dissolved or dispersed in the water before
administration.
o It is preferred that effervescent powders are packed in individual dose units in
airtight containers (e.g. laminated sachets)
Granules are preparations consisting of solid, dry aggregates of powder particles
sufficiently resistant to withstand handling. They are intended for oral administration.
Some are swallowed as such, some are chewed and some are some are dissolved or
dispersed in water or another suitable liquid before being administered.
o They are presented as single-dose or multi-dose preparations, and need to be kept
in a wide-mouthed, airtight container.
o There are several categories of granules, including:
These are uncoated granules generally containing acid substances and carbonates or
hydrogen carbonates which react rapidly in the presence of water to give release carbon
dioxide. They are intended to be dissolved or dispersed in water before administration.
Coated granules consist of granules coated with one or more layers of mixture of various
excipients.
Modified-release granules are coated or uncoated granules that contain special excipients
or which are prepared by special procedures, or both, designed to modify the rate, the
place or the time at which the active substances are released.
Session X: ———— -(Title)———————- 79
Gastro-resistant granules (also referred to as enteric-coated granules) are delayed release
granules that are intended to resist the gastric fluid and to release the active substance(s)
in the intestine fluid.
Session X: ———— -(Title)———————- 80
Worksheet 11.1: Reconstitution of Oral Rehydrating Salt (ORS)
Instructions :
Prepare sachets of Oral Rehydration Salts (O.R.S), jug or flask with closure which measures
more than 1 litre, purified water, measuring cylinder, and stirring rod. Review with students
the procedures of reconstituting as directed by the manufacturer.
Instructions/Procedures
o Read carefully the instructions on reconstitution of the oral powder/granule
preparation
o Find out/calculate the amount of diluent to be added
o Tap bottle/container to loosen the powder or granules
o Measure the volume of diluent to be added
o Open the container/bottle and pour half of the measured diluent into the bottle
containing the powder/granules medication
o Shake the mixture well and then add up the remaining half of the diluent to make
the final volume of the preparation and then shake well the preparation.
o NB: if there is a mark on the bottle to indicate the final volume, therefore diluent
is firstly added with caution not to reach the mark, well shaken then finely the
diluent is added to the mark required to make the final volume of the preparation.
o Then the Preparation is ready for use, label and dispense to patient.
o Pour one litre (four glasses) of boiled and cooled water into a clean container (Jug
or flask)
o Add contents of sachet (Powders) to water and stir to dissolve (using stirring rod
in this case)
o Then the product is ready for use.
Session X: ———— -(Title)———————- 81
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