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Optimizing Azithromycin Formulations: Choosing Between Compacted and Micronized Grades
Dec.19.2025

The Technical Challenges of Azithromycin

Azithromycin is a cornerstone of the macrolide antibiotic market, but from a manufacturing standpoint, it is notoriously difficult to handle. The API (Active Pharmaceutical Ingredient) is often "fluffy," possesses poor flowability, and is prone to static charge. For a production manager, these physical properties translate to uneven tablet weights and frequent machine stoppages.

To solve this, we offer two distinct physical forms: Compacted and Micronized (Micro).

Azithromycin Compacted: The Solution for High-Speed Tableting

If your facility focuses on the production of 250mg or 500mg tablets, Azithromycin Compacted is the industry standard for a reason.

  • Improved Bulk Density: The compaction process increases the density of the API, allowing for smaller tablet sizes—a major selling point for patient compliance.

  • Direct Compression Ready: By eliminating the need for complex granulation, you reduce the heat and moisture exposure that can lead to the formation of "Impurity B" and other degradation products.

  • Dust Reduction: Compacted granules minimize airborne particles, which is essential for protecting staff and maintaining the integrity of your cleanroom.

Azithromycin Micro/Powder: Precision for Pediatric and Liquid Forms

When the goal is an oral suspension or a fast-acting capsule, Micronized Azithromycin is required.

  • Enhanced Surface Area: Micronization increases the surface area-to-volume ratio, which is critical for the dissolution of Azithromycin Dihydrate, which is inherently poorly soluble in water.

  • Smooth Texture: For "dry syrups" or pediatric suspensions, a fine particle size is necessary to ensure a smooth mouthfeel and prevent a "gritty" texture that leads to patient rejection.

Managing the "Stickiness" Factor

Azithromycin is "sticky" by nature, which often leads to "picking" and "sticking" on tablet punches. Our technical team has refined our crystallization and drying process to ensure that our API has a lower static profile. When you use our material, you’ll notice less buildup on your tooling, leading to longer production runs and less downtime for cleaning.

Purity and Regulatory Assurance

Azithromycin is sensitive to acid hydrolysis. Therefore, the moisture content (as a Dihydrate) must be precisely controlled. Our product is tested rigorously for:

  1. Crystallinity: Ensuring the stable Dihydrate form for maximum shelf life.

  2. Impurity Profile: Strict monitoring of organic impurities to meet USP/EP standards.

  3. Solvent Residue: Using advanced chromatography to ensure the product is clean and safe for global markets.

Strategic Sourcing for Antibiotics

In the B2B sector, your supplier is your partner in regulatory success. We provide comprehensive dossiers and technical support to help your R&D team optimize the blend. Whether you are reformulating a generic or launching a new line, our Azithromycin grades provide the physical and chemical consistency required for a seamless scale-up.

Product link:https://arshinepharma.com/productdetail/Azithromycin-compacted-micro

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