Sterile and Eye Products Quiz

Sterility in Pharmaceutical Products

• Sterility is defined as the absence of viable microorganisms, but absolute sterility is often impractical for active ingredients.
• Functional sterility relies on procedural measures like clean room technology and Good Manufacturing Practices (GMP).
• Sterility Assurance Level (SAL) indicates the probability of one viable microorganism per defined quantity of drug products, expressed in logarithmic terms (e.g., -1 log = 1 in 10, -6 log = 1 in 1 million).
• Critical factors for sterility include bioburden, personnel and protective equipment (PPE), air quality, surface cleanliness, and effective sterilization practices.

Assessment of Sterility

• Endotoxins are lipopolysaccharides found in the outer membrane of Gram-negative bacteria and must be tested for sterility assurance.
• Visible and invisible particles must be monitored in injections to prevent contamination.
• Common pyrogens include endotoxins, which can induce fever.

Nanodispersion and Drug Formulation

• Nanodispersions utilize sodium carbonate and Poloxamer for stability, defined by their role as a buffering agent and stabilizer, respectively.
• Amorphous solid dispersion enhances drug solubility by disrupting the crystalline lattice structure.
• Polymorphs can exhibit varying solubility, where metastable forms typically have higher solubility than stable forms.

Particle Size and Drug Stability

• Laser diffractometry is used for particle size analysis, affecting drug stability—solid drugs are generally more stable than those in solution.
• Particle size affects sedimentation rates; smaller particles settle slower, influencing formulation stability.
• Aseptic manufacturing processes are essential to maintain sterility in drug formulations.

Eye Anatomy and Drug Delivery

• The anterior segment includes the cornea, conjunctiva, iris, ciliary body, and lens; the posterior segment contains the retina and optic nerve.
• Superior bioavailability for retinal delivery is achieved through suspensions due to increased corneal contact time.
• Potential excipients for ocular formulations include cyclodextrins (for solubilization), viscosity enhancers, penetration enhancers, preservatives, and buffering salts.

Sustained Release Devices

• Medicated contact lenses and intraocular devices minimize risks associated with repeated injections (e.g., retinal detachment).
• Vitrasert® is a sustained release device that delivers ganciclovir for months, ensuring continuous drug availability.
• The release profile varies between drops and inserts, influenced by formulation types and contact times.

Drug Loading and Release Dynamics

• The solubility of drugs impacts their loading in formulations; eye drops are limited by solubility, whereas inserts face fewer restrictions.
• Drug physical properties, such as particle size, significantly influence release dynamics and tissue penetration.
• Saline, simulating tears, minimally affects the retention and release of progesterone due to its solubility limitations.

Manufacturing and Storage Conditions

• Progesterone remains stable for three months at 40°C and 75% relative humidity, ensuring effective drug formulation and distribution.

This quiz covers key principles of sterility and the manufacturing of sterile products, specifically incorporating eye administration techniques. It is designed to test your understanding of the importance of sterility assurance as outlined by WHO guidelines. Prepare to explore the critical aspects of ensuring product safety and efficacy!