Formulasi dan Evaluasi Sediaan Suppositoria Bisakodil

Summary

This presentation explores the formulation and evaluation of bisacodyl suppositories, commonly used for treating constipation. It details the selection of active ingredients like bisacodyl and excipients such as Sera Alba, paraffin liquid, and BHT. The preparation involves precise weighing, melting, and molding of ingredients, followed by various tests to ensure quality. Evaluation methods include organoleptic tests, hardness testing, melting point assessment, dissolution tests, and HPLC to verify bisacodyl content. The final product is packaged in aluminum foil and labeled for distribution, ensuring effective delivery of the drug to the patient.

Takeaways

• 😀 The presentation focuses on the formulation and evaluation of bisacodyl suppositories, used to treat constipation.
• 😀 Bisacodyl, an active ingredient, is incorporated in suppositories, which are semisolid forms that are inserted into the anus or vagina.
• 😀 The formulation includes excipients like Serra Alba (to improve melting point), BHT (as an antioxidant), and paraffin oil (as a lubricant).
• 😀 The process for making suppositories involves melting the excipients, adding the active ingredient, and molding the final product.
• 😀 A key part of the preparation process is heating the mixture in a water bath and then cooling it in a fridge to form the suppositories.
• 😀 The suppositories are then wrapped in aluminum foil, packaged, and labeled accordingly before distribution.
• 😀 The evaluation of suppositories involves organoleptic tests (appearance, smell, and texture), ensuring quality and uniformity.
• 😀 Hardness testing is done to ensure the suppositories are not too brittle or soft, aiming for a target of 600-700 grams of force.
• 😀 The melting time of the suppository is tested to ensure it melts within 30 minutes in body temperature conditions.
• 😀 Dissolution testing is conducted to determine how effectively the active ingredient is released from the suppository into the body.
• 😀 High-performance liquid chromatography (HPLC) is used for precise measurement of bisacodyl content in the suppositories, ensuring the dosage is accurate and within the acceptable range.

Q & A

What is the main objective of the suppository formulation presented in the script?

The main objective of the suppository formulation is to prepare a bisacodyl-based suppository for treating constipation, with a focus on the preformulation and evaluation of the suppository's characteristics.

What active ingredient is used in the suppository formulation?

The active ingredient used in the suppository formulation is bisacodyl, which is commonly used to treat constipation.

What are the key components involved in the formulation of the suppository?

The key components include bisacodyl as the active ingredient, Serra Alba as a melting point enhancer, Oleum Cacao as a fat base, BHT as an antioxidant, and liquid paraffin as a lubricant.

Why is Serra Alba used in the formulation?

Serra Alba is used to enhance the melting point of the suppository, helping to raise or lower the melting point as needed and preventing crystallization.

What role does liquid paraffin play in the suppository formulation?

Liquid paraffin acts as a lubricant to maintain the consistency of the base, making the suppository softer and easier to use.

What is the purpose of the BHT (butylated hydroxytoluene) in the formulation?

BHT serves as an antioxidant, preventing the oxidation of the fat base and ensuring the stability of the suppository over time.

How is the suppository prepared according to the script?

The preparation involves weighing the ingredients, heating the Serra Alba and Oleum Cacao in a porcelain dish, adding bisacodyl and BHT, and then pouring the mixture into molds to solidify in a refrigerator. Afterward, the suppositories are wrapped in aluminum foil and packaged.

What tests are performed to evaluate the quality of the suppository?

The evaluation includes organoleptic tests (appearance, odor, color), hardness testing, melting time test, melting point test, dissolution test, and potency testing using high-performance liquid chromatography (HPLC).

How is the hardness of the suppository measured?

The hardness is tested by applying a weight (initially 600 grams) to the suppository and observing how long it takes for the suppository to break under pressure. The time and weight are adjusted to determine the hardness.

What is the purpose of the dissolution test for the suppository?

The dissolution test is conducted to measure the release rate of the active ingredient, bisacodyl, from the suppository into the surrounding fluid, simulating the release process in the body.