What is the purpose of each excipient? Why does the 1% strength contain less sodium chloride than the 0.5% strength? Why have other pharmacies requested your compounding pharmacy make these for them?
Case Study 6
Pilocarpine suspension eye drops
Due to a temporary shortage of pilocarpine eye drops in all brands, your compounding pharmacy has been approached by several pharmacies in your area to provide them with stock to continue patient therapy. You have the following referenced formulas:
Formula
|
|
0.5% Strength |
1% Strength |
|
Pilocarpine HCl |
0.5 g |
1 g |
|
NaCl |
0.8 g |
0.7 g |
|
Benzalkonium Chloride Solution |
0.02 mL |
0.02 mL |
|
Disodium Edetate |
0.05 g |
0.05 g |
|
Water for injection |
qs 100 mL |
qs 100 mL |
|
Sterilize by heating in an autoclave |
Questions
What is the purpose of each excipient?
Why does the 1% strength contain less sodium chloride than the 0.5% strength?
Why have other pharmacies requested your compounding pharmacy make these for them?
What are some quality control tests you may need to do if you are making large batches of this product?
What should you do with the product after you have taken samples for QC testing:
- Sell to the pharmacies and say you will call them if there are any issues
- Keep them in the LAFH until results are known so they don’t become contaminated
- Keep them in a quarantined area to be released when they have passed QC tests
The master formula suggests autoclaving, why are you doing this instead of using a filter?
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I need the answers for the last 3 questions please
Case Study 6
Pilocarpine suspension eye drops
Due to a temporary shortage of pilocarpine eye drops in all brands, your compounding pharmacy has been approached by several pharmacies in your area to provide them with stock to continue patient therapy. You have the following referenced formulas:
Formula
|
|
0.5% Strength |
1% Strength |
|
Pilocarpine HCl |
0.5 g |
1 g |
|
NaCl |
0.8 g |
0.7 g |
|
Benzalkonium Chloride Solution |
0.02 mL |
0.02 mL |
|
Disodium Edetate |
0.05 g |
0.05 g |
|
Water for injection |
qs 100 mL |
qs 100 mL |
|
Sterilize by heating in an autoclave |
Questions
What is the purpose of each excipient?
Pilocarpine HCl: Pilocarpine is the active ingredient in the eye drops and is a medication used to reduce intraocular pressure in conditions such as glaucoma. It stimulates certain receptors in the eye, leading to increased drainage of fluid and a reduction in pressure.
Sodium Chloride (NaCl): Sodium chloride is a salt that is added to the formulation for its tonicity-adjusting properties. It helps to maintain the osmotic pressure and physiological balance of the eye. The concentration of sodium chloride can vary depending on the desired strength of the eye drops.
Benzalkonium Chloride Solution: Benzalkonium chloride is a preservative that is commonly used in ophthalmic preparations to prevent microbial growth and contamination. It helps to maintain the sterility and integrity of the eye drops.
Disodium Edetate: Disodium edetate, also known as EDTA, is a chelating agent. It is added to the formulation to enhance the stability and shelf life of the eye drops by binding to metal ions that could promote degradation or oxidation of the active ingredient.
Water for injection: Water for injection is used as a solvent to dissolve and dilute the active and inactive ingredients, creating the suspension. It is important to use sterile water to ensure the safety and sterility of the eye drops.
Why does the 1% strength contain less sodium chloride than the 0.5% strength?
The reason for the difference in sodium chloride concentration between the two strengths may be related to the desired tonicity of the eye drops. Tonicity refers to the balance of solutes in a solution to match the osmotic pressure of the surrounding tissues. Different concentrations of sodium chloride may be used to achieve the desired tonicity for each strength of the eye drops while maintaining the efficacy and safety of the product.
Why have other pharmacies requested your compounding pharmacy make these for them?
It is likely due to the temporary shortage of pilocarpine eye drops in all brands. During a shortage, compounding pharmacies can play a crucial role in providing customized medications to meet the specific needs of patients when commercial products are not readily available.
What are some quality control tests you may need to do if you are making large batches of this product?
What should you do with the product after you have taken samples for QC testing:
- Sell to the pharmacies and say you will call them if there are any issues
- Keep them in the LAFH until results are known so they don’t become contaminated
- Keep them in a quarantined area to be released when they have passed QC tests
The master formula suggests autoclaving, why are you doing this instead of using a filter?
by Bartleby Expert
