T&E - Analítica


Active Interaction (active pharmaceutical ingredientes-API) / Excipient / Between Assets





When a drug is administered, biological variables, pH, solubility, enzymatic actions, among others, can occur, that is, a sum of energy variables acts for the product to be effective. The interaction, in addition to forming possible undesirable compounds the efficacy of the product, may alter solubility impacting the absorption of the drug, especially to solid forms in which absorption or release of heat affect it appreciably. Tests at different temperatures on the drug will allow early conclusions of interactions between the active (drug) and different excipients that can act on the effectiveness. With the calorimetric assay, it is possible to estimate the interaction of contact between the active and actives / excipients present in the formulation. In this way the pharmacotechnical sector, when developing, obtains more information about the impacts of the formulated, on the assays, such as Pharmaceutical Equivalence, Bioenvironment, Bioequivalence / Bioavailability, Dissolution and Comparative Dissolution Profiling (PDC).

Interaction between drugs normally occurs in combination compounds, such as injectables, which are administered indirectly in pockets containing serum or even more aggravating when more than one drug is inserted in the same bag, which may change, reduce its effectiveness or even forming toxic compounds. This fact also applies to fogging systems, presentations in association, combo type, among others.


Injectable Interaction: In hospitalized patients, injectable drugs are introduced together with saline (saline solution) or saline combinations with addition of glucose, lactose, among others, for slow and constant administration. Hospital serum consisting of the presence of sodium, potassium, chlorides, citrates or glucose, which can be isotonic, hypotonic and hypertonic established by the concentration of the components present and for use of the therapeutic need. The Compatibility / Stability check when adding injectable drugs in a serum bag are studied at different temperatures, assessing the availability of the active, osmosis measurements, particle changes, homogeneity among others over certain times.


RDC 53: It is important for the company to carry out the study of Forced Degradation or Degradation Impurities in accordance with RDC 53 of December 4, 2015 of ANVISA. This CDR within its reporting, identification and qualification limits completing pharmaceutical compatibility studies in the broad aspect of such impurities is predicted to be generated throughout the stability study. Some DRC (s) of ANVISA guide to studies of Pharmaceutical Compatibility, guidelines that should evolve to include situations important to the quality of the drug.





·         DSC: is the decision-making technique for the evaluation of degradation by interaction. This technique is usually used only.

·         TG/DTG: it is a complementary technique to the DSC, which allows two techniques to evaluate the degradation by interaction

·         IVFT: is a technique that identifies the products of the formulation. It can be used to verify the interaction, but requires that heating be performed separately.


The T&E budget is issued using the DSC technique. If the contractor considers another technique will be issued in the budget.


Note: TG / DTG is currently outsourced. Analysis of Pharmaceutical Compatibility or Drug-Excipient Interaction, have the following matrix.


     I.        DSC analysis of each asset (IFA)

   II.        DSC analysis of each Excipient

 III.        Analysis among Assets (IFA)

 IV.        Analysis of each Active with each excipient

   V.        Analysis of the mixture of the active ingredients with each excipient

 VI.        DSC, IVFT and TG / DTG on formulation and / or comparison to product Reference - OPTIONAL





The analytical techniques are based on the characteristics of each package, bibliographic research, composition sent by the manufacturer, packaging storage, collection and transport, among others. For such situations the T&E Center issues a questionnaire to collect as much information as possible to define the best analytical direction.


During the analytical test it may be necessary to extract or concentrate a possible contaminant signal, in this case it is possible to use several methodologies such as Liquid-Liquid extraction, SPE (Solid Phase Extraction), SPE (Solid Phase Micro Extraction), SBE (Stil Bar Extraction) and others for both organic and for metals.


Quantification Limits range from nanograms / mL, picograms / mL to phentograms / mL. The T & E center has equipment with sufficient detectability for even phentograms / mL. Among the analytical techniques commonly used for the interaction study are:


·         Thermal Analysis DSC or even TG / DTG

·         Gas-phase Chromatography (GC-FID-ECD-TCD-MS-Head Space);

·         Liquid phase chromatography (UPLC or HPLC-UV / Vis; Fluorescence; ELSD);

·         IVFT - transformed Fourier infrared;

·         UV / Vis absorption in ultra violet light and visible light;

·         Determination of peak purity using DAD.



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