1. Name and Identification

The active pharmaceutical ingredient is Tylosin Phosphate, identified by its CAS No. 1405-53-4. It is a crucial macrolide antibiotic, primarily formulated for oral administration via feed to treat and prevent bacterial infections in poultry and swine.

2. Chemical Characteristics

Tylosin Phosphate functions as a bacteriostatic agent by inhibiting bacterial protein synthesis. It achieves this by binding to the 50S ribosomal subunit, preventing the formation of peptide bonds. This mechanism makes it particularly effective against Gram-positive bacteria and a range of Mycoplasma species, which are common respiratory pathogens.

3. Physical Properties

Tylosin Phosphate typically presents as a white to yellowish powder. A key physical characteristic is its sparing solubility in water, while being more soluble in acidic solutions. This property makes it highly suitable for stable and uniform incorporation into animal feed, ensuring consistent drug delivery without clumping. It maintains excellent stability under recommended storage conditions.

4. Quality Specifications and Standards

5. Veterinary Applications

Tylosin Phosphate is expertly formulated for:

• Prevention and control of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae in chickens.
• Treatment of Infectious Sinusitis caused by Mycoplasma gallisepticum in turkeys.
• Prevention and treatment of Swine Dysentery (SD) caused by Brachyspira hyodysenteriae in pigs.
• Support for growth promotion and improved feed efficiency in poultry and swine at lower inclusion rates.
• Use in feed premixes for large-scale, consistent oral administration in farm animals.

Pharmacological Actions in Animal Health

Tylosin Phosphate, a well-established macrolide antibiotic, is a crucial tool in veterinary medicine, particularly for feed-based disease management:

• Mechanism of Action: It functions as a bacteriostatic agent by inhibiting bacterial protein synthesis. Tylosin Phosphate binds specifically to the 50S ribosomal subunit of susceptible bacteria, thereby preventing the formation of essential peptide bonds and disrupting bacterial growth. This mechanism is highly effective against a range of Gram-positive bacteria and crucial Mycoplasma species.
• Spectrum of Activity: Offers robust activity against key Gram-positive bacteria (e.g., Staphylococcus spp., Streptococcus spp.), various Mycoplasma species (e.g., M. gallisepticum, M. synoviae, M. hyopneumoniae), and certain Gram-negative anaerobes (e.g., Brachyspira hyodysenteriae).
• Pharmacokinetics in Animals: Following oral administration via feed, Tylosin Phosphate is absorbed from the gastrointestinal tract and widely distributed, accumulating in target tissues such as the lungs and gut. Its primary use in feed allows for consistent, low-level exposure, which is effective for disease prevention and control programs.
• Formulation Suitability: As a stable phosphate salt, it is ideally suited for incorporation into dry feed and premixes. This ensures excellent dispersion and consistent drug delivery throughout the animal's diet, critical for large-scale farm applications and long-term stability in feed.

Essential Chemical Attributes

• pH in Suspension: A 2.5% aqueous suspension of Tylosin Phosphate typically exhibits a pH range of 5.0–7.5, indicating its stability in formulations designed for feed application.
• Thermal Stability: The powder demonstrates reliable thermal stability, crucial for maintaining potency during feed manufacturing processes (e.g., pelleting) under recommended conditions.
• Light Sensitivity: Should be stored in light-resistant containers to prevent potential photolytic degradation, preserving its efficacy over time.
• Hygroscopicity: Possesses some hygroscopic properties. Containers must be kept tightly sealed to shield the material from moisture absorption and maintain its quality specifications during storage and handling.
• Solubility Characteristics: It is sparingly soluble in water but more soluble in acidic water, making it excellent for uniform dispersion in dry feed formulations rather than direct aqueous solutions.

Targeted Applications Across Animal Species

Our veterinary-grade Tylosin Phosphate is a cornerstone for effective disease prevention and management in poultry and swine:

• Poultry (Chickens & Turkeys): Essential for the prevention and control of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae in chickens, and Infectious Sinusitis caused by Mycoplasma gallisepticum in turkeys.
• Swine: Widely used for the prevention and treatment of Swine Dysentery (SD) caused by Brachyspira hyodysenteriae, and for reducing the incidence and severity of pneumonia caused by Mycoplasma hyopneumoniae.
• Growth Promotion: At specific low inclusion rates, it also functions as a highly effective growth promoter, improving feed efficiency and daily weight gain in both poultry and swine.
• Administration: Primarily incorporated into feed premixes, allowing for convenient and large-scale oral administration to entire flocks or herds.

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