Osmolality predictive models of different polymers as tools in parenteral and ophthalmic formulation development.

During the development of parenteral dosage forms, different physicochemical studies are required to ensure stable, effective and safe formulations. The osmolality of this kind of dosage forms should bear a close similarity to the body fluids to prevent local irritation, pain or even more significant side effects like endothelial damage. The osmotic studies performed in Polyethylene glycol 400 (PEG 400), Polyethylene glycol 4000 (PEG 4000), Poloxamer 407 (P407), Sodium Hyaluronate (SH), Chondroitin Sulphate Sodium (CS), Cremophor RH 40 (CRE40) and Polyvinyl alcohol (PVA) aqueous solutions, showed that the theoretical determination of the osmolality based on their molecular weight as the only determinant factor did not agree with the values obtained by the measurement of colligative properties such as the freezing point depression. The data obtained from this study and its analysis, provided predictive equations that can be used as tools in the primary development to estimate formulation's osmolality at different concentrations; and its evolution over a period at the hypothetical worst-case scenario of storage temperature

SeDeM Diagram: A New Expert System for the Formulation of Drugs in Solid Form

The SeDeM expert system is a methodology which is applied in preformulation and formulation studies of medicines specifically in solid dosage forms. This system informs on the physical profile of powdered substances (APIs and excipients) used to formulate drugs (Suñé et al, 2005; García et al, 2010; Aguilar et al, 2009). By determining whether powders (API or excipient) are suitable for direct compression, the SeDeM profile will inform about the advantages and gaps of those powdered substance to be used in direct compression, so the system informs on whether the direct compression method is appropriate (e.g.. wet granulation should be applied before compression). The characterization of powdered substances by SeDeM facilitates the identification of the characteristics that require amendment in order to obtain tablets by direct compression. This system thus provides information that will ensure the robust design of the formulation in the final product. This new method is based on the selection and application of several parameters that the formulation must fulfill to ensure a successful tablet elaborated by direct compression..

A new design for the review and appraisal of semi-solid dosage forms: Semi-solid Control Diagram (SSCD)

The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semisolid Control Diagram (SSCD) is used as an instrument for studying and evaluating semisolid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others

A new design for the review and appraisal of semi-solid dosage forms: Semi-solid Control Diagram (SSCD).

The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semi-solid Control Diagram (SSCD) is used as an instrument for studying and evaluating semi-solid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others

A new design for the review and appraisal of semi-solid dosage forms: Semi-solid Control Diagram (SSCD)

The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semisolid Control Diagram (SSCD) is used as an instrument for studying and evaluating semisolid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others

A new design for the review and appraisal of semi-solid dosage forms: Semi-solid Control Diagram (SSCD)

The Semi-solid Control Diagram (SSCD) is a new tool designed for the study of different excipients and different semi-solid dosage forms. It can be used to review and evaluate different formulations and/or batches and facilitate the selection of one of them that will present the most suitable galenic characteristics for topical application. It is also useful to track stability studies by comparing the diagrams, which allows to measure the impact of subjecting the formulation to different conditions and times to be examined. In this study, the Semisolid Control Diagram (SSCD) is used as an instrument for studying and evaluating semisolid pharmaceutical dosage forms, by comparing several different semisolid preparations (lipogels). With these results, the tool is validated and the best formulation has been discriminated from the others