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Frequently Asked Questions
Fluconazole is a triazole antifungal that inhibits fungal cytochrome P450 14-alpha-demethylase, blocking ergosterol synthesis in fungal cell membranes. Compared to other azoles, Fluconazole offers excellent oral bioavailability and tissue penetration, including into cerebrospinal fluid, making it the preferred choice for treating cryptococcal meningitis and systemic Candida infections. Its favorable safety profile and predictable pharmacokinetics make it suitable for both induction and maintenance therapy in immunocompromised patients.
Minocycline is a second-generation tetracycline that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, showing efficacy against methicillin-resistant Staphylococcus aureus (MRSA) and other multidrug-resistant organisms. Ofloxacin is a fluoroquinolone that inhibits bacterial DNA gyrase and topoisomerase IV, providing broad-spectrum coverage against Gram-positive and Gram-negative pathogens. Both APIs are valuable options for treating infections caused by bacteria resistant to first-line antibiotics, particularly in hospital-acquired infection settings.
Our anti-infective APIs undergo comprehensive microbiological testing including total aerobic microbial count (TAMC), total combined yeasts and molds count (TYMC), tests for specified pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella species, as well as endotoxin testing using the LAL method for injectable-grade APIs. All testing follows USP <61>, <62>, and <85> guidelines. Since these APIs are themselves antimicrobial agents, special neutralization and membrane filtration techniques are employed to ensure accurate microbial enumeration.
Yes, we can supply anti-infective APIs with specific particle size specifications optimized for oral suspension formulations. Particle size is critical for suspensions as it directly affects the rate of dissolution, bioavailability, and physical stability of the suspension. We can provide APIs with D90 specifications ranging from micronized grades (<10 microns) for enhanced dissolution to controlled coarse grades for prolonged release. We work with customers to determine the optimal particle size distribution for their specific suspension formulation requirements.
Povidone Iodine is an iodophor that works by releasing free iodine which penetrates microbial cell walls and oxidizes essential proteins, nucleic acids, and fatty acids, leading to rapid microbial death within 30-60 seconds. It has broad-spectrum activity against bacteria, fungi, viruses, and protozoa. Chlorhexidine Gluconate is a cationic bisbiguanide that disrupts microbial cell membranes, causing precipitation of cell contents and cell death. It provides persistent antimicrobial activity for up to 6 hours after application and is preferred for surgical hand scrubs and preoperative skin preparation due to its residual effect.
