dissolution rate

IRI: https://spec.industrialontologies.org/ontology/construct/DissolutionRate

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/

SubClass Of: rate process profile

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › bfo:process profile › rate process profile › dissolution rate

Definition

rate process profile at which a solute dissolves in a solvent

Explanatory Notes

Dissolution rate describes how fast a solute enters solution under defined conditions and is typically expressed as an amount (or concentration) dissolved per unit time. It is a non-equilibrium, time-dependent behavior that precedes attainment of the solubility limit (equilibrium saturation). Dissolution occurs at the solid–liquid interface, where solvent contacts the solid surface and solute molecules detach and diffuse into the bulk liquid. The observed rate is governed by the solute’s surface area and physical form (e.g., particle size and wetting), solute–solvent interactions, temperature, mixing/agitation (hydrodynamics), and mass-transfer factors such as diffusion boundary layer thickness, as well as the driving force to saturation (difference between the saturation concentration and the current bulk concentration). Experimentally, dissolution rate is determined by monitoring how dissolved concentration (or dissolved mass) changes over time under a specified method, and it is used to evaluate and control how quickly solid components (e.g., salts, buffers, active ingredients) reach the required dissolved state in process preparation and formulation contexts.

Examples

• dissolution rate of sodium chloride in water during buffer preparation; dissolution rate of powdered cell culture medium in water during media preparation; dissolution rate of sucrose in an aqueous reaction mixture; dissolution rate of an active pharmaceutical ingredient during formulation development;

Adapted From

• https://www.fda.gov/media/148472/download and https://www.ncbi.nlm.nih.gov/books/NBK431100/#:~:text=%5B1%5D%5B2%5D%5B,/L%20or%20g/L

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs to create necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

DissolutionRate(x) → RateProcessProfile(x) ∧ ∃s (Solute(s) ∧ hasParticipantAtSomeTime(x, s)) ∧ ∃p (Process(p) ∧ processProfileOf(x, p) ∧ ∃v (Solvent(v) ∧ hasParticipantAtSomeTime(p, v)))

Semi-Formal Natural Language Axioms

if x is a ‘dissolution rate’ then x is a ‘rate process profile’ that ‘has participant at some time’ some ‘solute’ and is the ‘process profile of’ some ‘process’ that ‘has participant at some time’ some ‘solvent’

Description Logic

constr:DissolutionRate ⊑ constr:RateProcessProfile

constr:DissolutionRate ⊑ ∃ bfo:has_participant_at_some_time .constr:Solute

constr:DissolutionRate ⊑ ∃ constr:processProfileOf .(bfo:process ⊓ ∃ bfo:has_participant_at_some_time .constr:Solvent)

SubClassOf: constr:RateProcessProfile

SubClassOf: bfo:has_participant_at_some_time some constr:Solute

SubClassOf: constr:processProfileOf some (bfo:process and bfo:has_participant_at_some_time some constr:Solvent)