Azithromycin PFS Formulation and Manufacturing Process
Learn how to prepare Azithromycin PFS formulation and manufacturing process that ensures high-quality and reliable production in the pharmaceutical industry.
Product Name: Azithromycin PFS
Concentration: Azithromycin USP 200 mg / 5 ml
Batch Size (Kg): 40.00 kg
Batch Quantity (Phial): 2000 bottles (35 ml bottle)
Master Formula
| Item No. | Name of Raw Materials | Specification | Unit | Theoretical Amount | Functions |
| 1 | Azithromycin Dihydrate (Micronized) | USP | Kg | **2.940 | Active |
| 2 | Xanthan Gum | USP | Kg | 0.160 | Excipient |
| 3 | Dispersible Cellulose | BP | Kg | 0.070 | Excipient |
| 4 | Polyethylene Glycol 6000 | USP | Kg | 0.400 | Excipient |
| 5 | Disodium Edetate | BP | Kg | 0.050 | Excipient |
| 6 | Sodium Benzoate | BP | Kg | 0.140 | Excipient |
| 7 | Tribasic Sodium Phosphate (Anhydrous) | USP | Kg | 0.090 | Excipient |
| 8 | Aspartame (Powder) | USP | Kg | 1.400 | Excipient |
| 9 | SD Banana Flavor (Powder) | Ph.Gr. | Kg | 0.700 | Excipient |
| 10 | Titanium Dioxide | BP | Kg | 0.140 | Excipient |
| 11 | Colloidal Anhydrous Silica (Aerosil 200) | USP | Kg | 0.630 | Excipient |
| 12 | Sucrose | BP | Kg | **33.280 | Sweetening agent and weight adjuster |
Note: (**) these should be calculated
Calculation 1: Azithromycin should be calculated as per potency.
Calculation 2: Sugar should be adjusting with Azithromycin raw material which calculated as per potency.
Manufacturing Process
A. Mixing & Drying of Excipients:
1. Sieve the following materials one after another through # 40 mesh screen and place them into a poly bag. Finally mix for 5 minutes manually.
| Name of the item | Quantity (Kg) | Note |
| Xanthan Gum | 0.160 | |
| Dispersible Cellulose | 0.070 | |
| Disodium Edetate | 0.050 | |
| Sodium Benzoate | 0.140 | |
| Tribasic Sodium Phosphate (Anhydrous) | 0.090 | |
| Titanium Dioxide | 0.140 | |
| Colloidal Anhydrous Silica (Aerosil 200) | 0.630 |
2. Dry the blend of step 1 in a tray dryer at (70-75) 0C for three 1 hour & 30 minutes to achieve %LOD below 1.0%.
Observed Temperature: ______0C and %LOD: ________%.
B. Crushing of Sucrose:
3. Crush Sucrose using Multi-mill by passing through 1.0 mm screen at medium speed in Sugar Crushing area.
| RM | Quantity (Kg) | Note |
| Sucrose | Calculation No. 2 |
C. Premixing & Blending:
4. Pass the following items through # 40 mesh screen & transfer into the Double Cone Blender.
| RM | Quantity (Kg) | Note |
| Azithromycin Dihydrate (Micronized) | Calculation No. 1 | |
| Aspartame (Powder) | 1.400 | |
| SD Banana Flavor (Powder) | 0.700 | |
| Polyethylene Glycol – 6000 | 0.400 | |
| Sucrose | Calculation No. 2 |
5. Add 15 Kg of the crushed Sucrose into the Double Cone Blender (at step 4) by passing through # 20 mesh screen and blend for 5 minutes.
6. Add the dried materials of step 2 at step 5 (into the Double Cone Blender) and mix for 10 minutes.
7. Add remaining portion of the Crushed Sucrose at step 6 (into the Double Cone Blender) by passing through # 20 mesh screen. Then blend for 15 minutes.
8. Finally collect the mixed granules into the container and fix a product label outside the Drum, then store them for filling.