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Jan 18
The formulation of capsules involves several steps. Here is a general outline of the process:
1. Selection of active ingredients: Determine the active ingredients that need to be included in the capsule formulation based on the desired therapeutic effect.
2. Excipient selection: Choose suitable excipients such as fillers, binders, lubricants, and disintegrants. These excipients help in achieving the desired physical properties of the capsule and aid in the manufacturing process.
3. Pre-blending: Pre-blend the active ingredients and excipients in the required proportions to ensure uniform distribution of the ingredients.
4. Granulation (if required): In some cases, granulation may be necessary to improve the flowability and compressibility of the powder mixture. This step involves wetting the powder mixture with a binder solution and then drying and milling it to obtain granules.
5. Mixing: Mix the pre-blended or granulated powder mixture thoroughly to ensure homogeneity.
6. Capsule filling: Fill the mixed powder into empty capsules using a capsule filling machine. The machine separates the capsules, fills them with the powder, and then joins the capsule halves together.
7. Capsule sealing: If required, seal the filled capsules to prevent any leakage or tampering. This step is typically done using a capsule sealing machine.
8. Quality control: Perform quality control tests on the filled capsules to ensure they meet the required specifications for weight, content uniformity, dissolution, and other parameters.
9. Packaging: Package the filled and sealed capsules in suitable containers, such as blister packs or bottles, and label them with necessary information like dosage instructions, batch number, and expiry date.
It is important to note that the specific steps and requirements may vary depending on the type of capsule (e.g., hard gelatin capsules or soft gelatin capsules) and the specific formulation being developed.
1. Selection of active ingredients: Determine the active ingredients that need to be included in the capsule formulation based on the desired therapeutic effect.
2. Excipient selection: Choose suitable excipients such as fillers, binders, lubricants, and disintegrants. These excipients help in achieving the desired physical properties of the capsule and aid in the manufacturing process.
3. Pre-blending: Pre-blend the active ingredients and excipients in the required proportions to ensure uniform distribution of the ingredients.
4. Granulation (if required): In some cases, granulation may be necessary to improve the flowability and compressibility of the powder mixture. This step involves wetting the powder mixture with a binder solution and then drying and milling it to obtain granules.
5. Mixing: Mix the pre-blended or granulated powder mixture thoroughly to ensure homogeneity.
6. Capsule filling: Fill the mixed powder into empty capsules using a capsule filling machine. The machine separates the capsules, fills them with the powder, and then joins the capsule halves together.
7. Capsule sealing: If required, seal the filled capsules to prevent any leakage or tampering. This step is typically done using a capsule sealing machine.
8. Quality control: Perform quality control tests on the filled capsules to ensure they meet the required specifications for weight, content uniformity, dissolution, and other parameters.
9. Packaging: Package the filled and sealed capsules in suitable containers, such as blister packs or bottles, and label them with necessary information like dosage instructions, batch number, and expiry date.
It is important to note that the specific steps and requirements may vary depending on the type of capsule (e.g., hard gelatin capsules or soft gelatin capsules) and the specific formulation being developed.
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