Trituration: is a technique that involves grinding substances into

a fine powder using a mortar and pestle.

This process serves several purposes:
1. Reducing Particle Size:
* Improved Dissolution: Smaller particles dissolve more readily,
enhancing drug absorption.
* Enhanced Drug Release: Smaller particles can more easily
pass through membranes and be released into the bloodstream.
* Improved Uniformity: Grinding ensures a consistent particle
size, leading to more accurate dosing.
2. Mixing Powders:
* Homogeneous Mixtures: Trituration helps to evenly distribute
different powders, creating a uniform mixture.
* Improved Drug Stability: Mixing can prevent degradation of
certain drugs, especially when combined with other substances.
 Pulverization: is a common technique used in pharmacy to
reduce solid materials into a fine powder.
▪ This process has several important applications in the
pharmaceutical industry:
Methods of Pulverization:
* Pulverization by Intervention: This technique involves adding
a small amount of a liquid (e.g., alcohol) to a hard or gummy
drug substance to facilitate grinding. The liquid evaporates,
leaving behind a fine powder.
 Geometric dilution: is a technique used to achieve a
homogeneous mixture of two or more substances with
significantly different quantities.
▪ It's particularly useful when you have a small amount of a
potent ingredient that needs to be evenly distributed in a larger
amount of a diluent.
How geometric dilution works:
* Start with the smaller quantity: Place the ingredient present in
the smaller quantity (the potent ingredient) in a mortar or other
mixing vessel
* Add an equal amount of diluent: Add an equal amount of the
diluent (the larger quantity ingredient) to the mortar.
* Mix thoroughly: Mix the two ingredients together until they
are thoroughly blended.
* Repeat the process: Add another equal amount of the diluent
to the mixture and mix again.
* Continue the process: Repeat step 4 until all of the diluent has
been added and the mixture is completely homogeneous.
 Why use geometric dilution?
* Ensures even distribution: By adding the diluent in equal
increments and mixing thoroughly at each step, geometric
dilution ensures that the potent ingredient is evenly distributed
throughout the mixture.
* Prevents clumping: It helps to prevent clumping of the potent
ingredient, which can lead to uneven distribution and inaccurate
dosing.
* Reduces the risk of error: Geometric dilution is a systematic
approach that minimizes the risk of errors in the mixing process.
● By following the principles of geometric dilution, you can
achieve accurate and consistent mixtures, even when dealing
with significant differences in ingredient quantities.
Introduction to Filtration in Pharmacy
• Filtration is a separation technique that involves passing a
liquid or gaseous fluid through a porous medium to remove
suspended particles.
• In pharmacy, filtration is a critical process used for various
purposes, including:
 * Clarification of liquids: Removing insoluble particles from
solutions or suspensions.
* Sterilization: Removing microorganisms from solutions to
ensure product sterility.
* Purification: Isolating specific components from a mixture.
Types of Filtration Methods in Pharmacy
1. Gravity.
2. Low pressure vacuum.
3. High pressure syringe or pump.
4. Centrifugation.
• Types of filtering media:
1. Filter paper.
2. Membrane filters.
3. Others such as cotton filters, fiber glass filters and glass-wool
filters
 Storage conditions
● Stability of drugs depends on both environmental factors such
as temperature, air, light and humidity, and drug-related factors
such as the active ingredient itself, the dosage form (tablet,
solution, etc.) and the manufacturing process.
● It is therefore necessary to respect storage instructions given
in this guide or by manufacturers (on notices and labels) if the
recommendations are not identical.
● Information regarding storage conditions must be written in
the label of each pharmaceutical product.
Temperature
▪ The temperature in the store should not be above 25 (30) °C.
Storage temperatures are defined by European pharmacopoeia
as follows:
freezer – 15 to 0 °C
refrigerator + 2 to + 8 °C
cool + 8 to + 15 °C
ambient + 15 to + 25 °C
temperature
• General terms of storage conditions
Term Meaning
* Any temperature not above 8 °C.** Refrigerator
Cold
or freezer?
* Any temperature between 8 -15 °C.* Items may
Cool
be stored in a refrigerator.
* “The temperature prevailing in a working area” .*
Room temperature
20-25 °C & allows variations 15-30 °C.

Warm temperature Any temperature between 30 -40 °C.

Excessive heat Above 40°C.

Protection from freezing Don’t freeze.

 Expiration
● Drugs deteriorate progressively and according to various
processes, even if stored in adequate conditions.
▪ Drug expiration refers to the date after which a pharmaceutical
product is no longer guaranteed to be safe and effective.
▪This date is typically printed on the product label and is
determined through rigorous stability testing conducted by the
manufacturer.
▪ The expiry date indicated by manufacturers designates the
date up to and including which the therapeutic effect remains
unchanged (at least 90% of the active ingredient should be
present and with no substantial increase in toxicity).
▪ The expiry date should be indicated on the label with storage
instructions.
Why Do Drugs Expire?
● Drugs are chemical compounds that can degrade over time
due to various factors, including:
* Chemical Degradation: Chemical reactions can break down
the active ingredients in a drug, reducing its potency and
potentially forming harmful byproducts.
* Physical Degradation: Physical changes, such as evaporation,
crystallization, or color change, can affect a drug's stability and
efficacy.
 * Microbial Contamination: Microorganisms can contaminate
drugs, especially those in liquid or semi-solid forms, leading to
spoilage and potential infection.
Importance of Adhering to Expiration Dates
Using expired medications can have serious consequences,
including:
* Reduced Efficacy: Expired drugs may not be as effective as
intended, leading to treatment failure.
* Increased Risk of Adverse Effects: Degraded drugs may cause
adverse reactions or toxicity.
* Potential for Harm: In some cases, expired medications can
become contaminated or contain harmful by-products.
Difference between Expiry date & Shelf life of Pharmaceuticals
• Shelf life (t90): is the time required to reduce the
concentration of drug to 90% of its initial concentration.
• Shelf life relates to drug’s quality over certain period of time,
• while the expiry date relates to both quality & safety of
medication at specific point in time.
 PHARMACEUTICAL PACKAGING
Containers and Closure Systems
The choice of container and closure system for a pharmaceutical
product is critical to ensure its stability, safety, and efficacy. Key
considerations include:
* Material Compatibility: The container and closure material
must be compatible with the formulation to prevent interactions
that could degrade the product.
* Barrier Properties: The container must provide adequate
protection against moisture, oxygen, light, and microbial
contamination.
* Ease of Use: The container and closure should be designed for
easy opening, dosing, and dispensing.
* Child Resistance: For certain products, child-resistant closures
are required to prevent accidental ingestion by children.
Common Container Types:
* Glass Containers:
* Type I: High hydrolytic resistance, suitable for sensitive drugs.
* Type II: Moderate hydrolytic resistance.
* Type III: Low hydrolytic resistance, suitable for less sensitive
drugs.
 * Plastic Containers:
* Polyethylene (PE): Flexible, moisture-resistant, but may not be
suitable for all formulations.
* Polypropylene (PP): Rigid, heat-resistant, and chemically resistant.
* Polyvinyl Chloride (PVC): Flexible, transparent, and relatively
inexpensive, but may leach plasticizers.
* Metal Containers:
* Tinplate: Used for aerosols and some solid dosage forms.
* Aluminum: Used for some sterile products and oral solid dosage
forms.
Labeling
▪ Accurate and informative labeling is essential for safe and
effective use of pharmaceuticals.
● Key labeling requirements include:

* Product Name: The generic and brand name of the drug.

* Strength and Dosage Form: The quantity and form of the
active ingredient(s).
* Indications and Usage: The conditions for which the drug is
intended.
* Dosage and Administration: Instructions for proper use of the drug.
* Warnings and Precautions: Potential risks and side effects
associated with the drug.
* Storage Instructions: Guidelines for proper storage of the drug.
* Expiration Date: The date after which the drug should not be used.
* Lot Number: A unique identifier for each batch of the drug.
* Manufacturer's Information: The name and address of the
manufacturer.
Package Insert
The package insert provides detailed information about the drug,
including:
* Description: The chemical and physical properties of the drug.
* Clinical Pharmacology: The mechanism of action and pharmacodynamics
of the drug.
* Indications and Usage: The specific conditions for which the drug is
indicated.
* Contraindications: Conditions under which the drug should not be
used.
* Warnings and Precautions: Potential risks and side effects associated
with the drug.
* Adverse Reactions: Common and serious adverse effects that may
occur.
* Drug Interactions: Interactions with other drugs or substances.
* Use in Specific Populations: Information on use in pregnant women,
nursing mothers, and children.
* Overdosage: Symptoms and treatment of overdose.
* Dosage and Administration: Detailed instructions for proper use of
the drug.
* How Supplied: Information about the drug's packaging and available
dosage forms.