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Questions and Answers
What is the primary reason for the addition of binder as a solution in wet granulation?
Which of the following is an advantage of the wet granulation method?
What is the primary purpose of granulation in tablet preparation?
Which method involves binding powder particles using an adhesive?
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What is considered a limitation of the wet granulation process?
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What is NOT a reason for performing granulation?
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Which step is NOT part of the wet granulation process?
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Why might stability considerations be significant in the wet granulation method?
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Which binder addition method is most commonly used in wet granulation?
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What is a characteristic of the granulation liquid used in wet granulation?
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Study Notes
Granulation
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Granules are dry aggregates of powder particles, often containing API(s) and excipients.
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They can be taken directly, dispersed in food, or dissolved in water.
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Granulation improves flowability and compressibility of powders.
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Granulation ensures uniform fill of the die cavity and good tablet formation.
Wet Granulation
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Wet granulation uses a liquid binder to create granules.
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The binder is added either dissolved or suspended in a granulation liquid (usually water or alcohol).
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The method of binder addition (liquid or dry) depends on its solubility and the formulation.
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Overwetting can cause clumps, sieve blockage, and slow drying.
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Underwetting can lead to soft, crumbly tablets.
Advantages of Wet Granulation
- Improves flowability and compressibility, reducing compression pressure and energy.
- Suitable for high-dose drugs with weak compressibility that are stable to heat and moisture.
- Maintains uniform distribution for low-dose drugs.
- Improves dissolution rate of hydrophobic drugs due to moisture.
- Prevents particle segregation, enhancing content uniformity.
Disadvantages of Wet Granulation
- Expensive due to labor, time, equipment, energy, and space requirements.
- Material loss during processing.
- Stability concerns for moisture-sensitive or thermolabile drugs.
- Multiple steps increase complexity, validation, and control difficulties.
- Incompatibility between formulation components may be aggravated.
Wet Granulation Steps
- Weighing and Blending: Ingredients are weighed and blended except for the lubricant.
- Granulation: Binder solution is added dropwise until a wet mass is achieved.
- Sieving I: The wet mass is sieved to create granules of desired size.
- Drying: The wet granules are dried for 10 minutes.
- Sieving II: Dried granules are sieved to ensure homogeneous size and shape.
- Lubrication: The granules are weighed and an appropriate amount of lubricant is added.
- Compression: The lubricated granules are compressed into tablets.
Sulfadiazine
- Model drug for wet granulation.
- Weak base, white powder, stable in dry air, not affected by moisture or heat, but decomposes in light.
- Sulfa drugs are not suitable for direct compression due to poor flowability and high doses.
Practical Considerations
- Fillers: Lactose, microcrystalline cellulose, starch, sucrose, and calcium phosphate are commonly used.
- Filler Choice: Based on manufacturer experience, relative cost, and compatibility with formulation ingredients.
- Calcium Salts: Avoid using calcium salts as fillers with tetracycline antibiotics due to reduced absorption.
- Wetting: Care must be taken to avoid overwetting or underwetting.
- Drying: Granules should retain some moisture to act as a binder.
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Description
This quiz explores the fundamental concepts of granulation, particularly focusing on the wet granulation process. Participants will learn about the advantages, methods, and challenges associated with creating granules. Perfect for pharmacy students and professionals seeking to enhance their knowledge of drug formulation.
