Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

EXERCISE NO. 6

PREPARATION OF MAGNESIUM SULFATE PILLS

I. Intended Learning Outcomes:

At the end of the exercise, the student should be able to
1. Identify the ingredients based on their physical characteristics and describe
their function in the preparation
2. Compound Magnesium Sulfate Pills using appropriate method of preparation
3. Select appropriate container for the product
4. Prepare the label for the product accurately and neatly
5. Comply with the standards and regulations set by CGCP

II. Discussion:
Pills solid oral dosage form consist of one or more medicaments incorporated in
a small, round, spherical or ovoid mass that are intended for oral administration. Pills
were formerly the most extensively used oral dosage form, but they have been replaced
largely by compressed tablets and capsules. They were perceived to be relatively easy
to make and compact in quantity, masked bitter or unpleasant tastes and odors, were
stable for long periods and can be administered in this form if the dose is not too large.

In order to compound pills by hand, a pill base or mass was constructed from
which the prescriber often directed that a given weight of mass should be made into a
specified number of pills. The pill mass consisted of two parts: the active ingredients and
the excipient, which gave the mass the appropriate consistency of adhesiveness,
firmness and plasticity. A generic pill excipient would probably contain glucose, glycerin,
powdered acacia and benzoic acid. The latter was often used as a preservative and might
be omitted if only a small batch of pill mass was being compounded. This excipient
formed a colorless, very adhesive liquid that was usually prepared in advance of
compounding the pills.

The active ingredients and excipient were triturated in a mortar with a special pill
pestle and kneaded into a homogeneous mass that could be divided into the desired
weight. The required weight of mass was then rolled into an elongated cylinder on a pill
tile, which often incorporated a measuring scale to aid cutting and division. Small
quantities of mass were rolled using a pill spatula that had very little ‘spring’ and
featured a broad end or a flat impervious board. The cylindrical pill mass was then cut
either by hand or using a pill divider (a grooved roller) and then rolled into the final
shape using a pill roller (resembling interlocking jar lids) or between the fingers.

The steps in making pills (1) Forming a mass and kneading using a mortar and
pestle (2) hand rolling (3) packaging.

Pills are classified to its weight (1) parvules (small pills) weighs less than 20 mg
(2) granules weigh between 20 mg to 60 mg (3) boluses known as the big pills weigh
between 700 mg to 2000 mg commonly for veterinary use

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

III. Materials
Hard Soap, Finely Powdered Medicine Dropper
Magnesium Sulfate Mettler balance
Purified water Mortar and Pestle
Pill Tile Spatula (Porcelain or Metal)

IV. Formula
Magnesium sulfate, finely powdered..................13 g
Hard Soap, finely powdered...............................13 g
Purified water, qs.ad.....................................100 pills

V. Compounding Procedure
1. Weigh all the ingredients accurately.
2. Triturate magnesium sulfate powder and hard soap in mortar and pestle.
3. Add distilled water, drop by drop until a damp mass is formed.
4. Divide the mass using block and divide method.
5. Mold the individual mass by means of your palm
6. Place in an appropriate container.
7. Label properly.

VI. Questions:
1. What are pills? Are they still manufactured?
2. What are the four general steps in preparing pills?
3. Do you consider all pills as contraceptives? Why?

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

Name: ________________________________ Date: ______________________

Year and Section: _______________________ Rating: ____________________

EXERCISE NO. 6

PREPARATION OF MAGNESIUM SULFATE PILLS

Synonym/Latin Name:
Use of Preparation:
Method of Preparation:
Appropriate Container:
Storage Condition:

Formula for 5 pills:

Ingredients Quantity Use in Formula

Calculations:

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

Answers to Question:
1. What are pills? Are they still manufactured?

2. What are the four general steps in preparing pills?

3. Do you consider all pills as contraceptives? Why?

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

RUBRICS FOR PHARMACEUTICS 1 (LAB) PREPARATION

5 4 3 2
Exemplary Accomplished Developing Beginning
Skills
Procedural Student thoroughly Student follows the Student follows the Student follows the
Knowledge and carefully procedure with sufficient procedure with procedure with full
followed each supervision minimal or limited supervision
procedure supervision

Use of Student uses Student Uses tools, Student Uses tools, Student Uses tools,
Equipment appropriate tools, equipment and equipment and equipment and
equipment and materials with sufficient materials with limited materials with full
materials with control or minimal control supervision in
evidence of control in manipulating
manipulating
Return of Student always Student Returns Student Requires Student Requires
Equipment return clean equipment with only some reminders to constant reminders
equipment with no minimal reminders return equipment to return equipment
reminders
PPE, Student is tidy, with Student is mostly tidy, Student is sometimes Student is untidy,
Courtesy complete laboratory wears the complete tidy, wears incomplete wears only laboratory
and safety gear (head cap, lab laboratory gear after laboratory gear, gown, not respectful
gown, mask and being reminded, mostly sometimes respectful of others, not mindful
gloves) respectful of respectful of others, of others, sometimes of safety, and leaves
others, mindful of mostly mindful of safety, mindful of safety, and the area messy even
safety, and leaves and leaves the area leaves the area messy after being reminded.
the area clean clean only after being even after being
reminded. reminded.
Product
10 8 6 4
Exemplary Accomplished Developing Beginning
Final Student’s final Student’s final product Student’s final product Student’s final
Product product conforms to minimally conform to the minimally conform to product does not
the expected expected outcome with the expected outcome conform to the
outcome 1 mistake 2-3 mistakes expected outcome
*Elegance
*Stability
*Same size and
shape
hardness
Packaging Student Student displays a good Student shows some Student does not
and demonstrates an understanding of how to understanding of how demonstrate
labelling accurate and label the product. to label the product. understanding of
complete Layout organized in a Layout somewhat how to label the
understanding of how satisfactory manner but organized with lack of product. Layout
to properly label the lack 1 information 2-3 information poorly arranged; lack
product. Layout well presented Layout was totally dis- more than 4
organized with Layout was not aligned align information
proper alignment properly The size of the label is The total appearance
The container used is Label was not properly not appropriate for the of the label is
clean and attached but is it neat. container unpresented
appropriate The container used is The container used is The container used
somewhat clean and dirty is not appropriate
appropriate

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

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