药品片的应力度灵敏度:相当裂的概念和微观结构的考虑

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

Stress concentration is when stress intensifies near discontinuities such as holes or abrupt cross-sectional changes in a structural member. This localized stress can often surpass the average stress within the member. The stress distribution in flat bars, either with a circular hole or varying widths connected by fillets, can be determined experimentally using a photoelastic method. The results are based on ratios of geometric parameters like the ratio of the hole's radius to the smaller...

The concept of stress concentration is crucial for understanding how materials respond under bending stresses, particularly when there are irregularities or discontinuities in the material's geometry. Normally, stress in a symmetric member subjected to pure bending is assumed to be uniformly distributed across the entire cross-section. However, this assumption does not hold when there are variations in the cross-sectional geometry or the presence of notches and holes.
The stress...

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...

Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...