Liquid dosage forms intermediate

The high relative humidity conditions cited in Table 4 apply to APIs and solid dosage forms. Low relative humidity conditions should be used for liquid drug products in semipermeable container-closure systems. The ICH Draft Revised Stability Guidance suggests low RH conditions of 40%+ 5% relative humidity for long-term studies, 60%+ 5% relative humidity for intermediate studies, and not more than 25% RH accelerated studies. 

The main choice will be between an oral solution and an oral suspension. For some active substances an emulsion or solubilisate is the appropriate form. However in some cases (e.g. because of an intermediate solubility of the active substance) the pharmacist will have no other option than to dispense an oral solid dosage form and instruct the patient how to manipulate it safely (see Sect. 37.6.2). Proper consideration of the options may prevent formulation mistakes with probably severe consequences. This especially applies to the unreflected use of suspending bases for rendering an oral solid into an oral liquid. 

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