[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_etc=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”10px” padding_top=”” padding_right=”” padding_bottom=”” padding_left=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

COMPATIBILITY STUDY

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

API INTERACTION, EXCIPIENT, FINISHED PRODUCT and PACKAGING MATERIAL

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_etc=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_size=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=””][fusion_builder_row][fusion_builder_column type=”2_3″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”ast-content-ul-list bullet” id=””]

The compatibility study in a pharmaceutical formulation aims to analyze the stability of the active pharmaceutical ingredient (API) drug against the other components of the formulation, based on the observation of possible interactions between the components in different test environments.

NanoBusiness offers the following options:

Following the convenient methods.

[/fusion_text][fusion_menu_anchor name=”ifaxexcipientes” class=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

[fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#1a80b6″ top_margin=”” bottom_margin=”” border_size=”3″ icon=”” icon_circle=”” icon_circle_color=”” width=”32%” alignment=”left” /]

ACTIVE PHARMACEUTICAL INGREDIENT x EXCIPIENTS

Analyzing the compatibility between an excipient and the API is essential to develop a drug formulation. Although pharmacologically inert, excipients can physically and chemically interact with it, causing a variation in their aimed function.

Chemical reactions such as decomposition, oxidation, permeation and displacement may occur, changing the drug structure and physiological properties. Therefore, analysis of binary mixtures is mandatory by the Brazilian Health Surveillance Agency (ANVISA).[top]

[/fusion_text][fusion_menu_anchor name=”paxembalagem” class=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

[fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#1a80b6″ top_margin=”” bottom_margin=”” border_size=”3″ icon=”” icon_circle=”” icon_circle_color=”” width=”30%” alignment=”left” /]

FINISHED PRODUCT x PACKAGING

Physical and chemical changes in the packaging material can cause an improper interaction between its components and API, promoting product instability. Therefore, to maintain its stability, it is essential to choose a packaging container compatible with the active substance and/or excipients, and that is suitable for the pharmaceutical form.

Moreover, the packaging material must protect the pharmaceutical product from environmental factors, as high humidity, for example, is also a major risk factor and can compromise the drug quality.[top]

[/fusion_text][fusion_menu_anchor name=”completooupreliminar” class=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

[fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#1a80b6″ top_margin=”” bottom_margin=”” border_size=”3″ icon=”” icon_circle=”” icon_circle_color=”” width=”30%” alignment=”left” /]

COMPLETE OR PRELIMINARY STUDY

The complete compatibility study includes the analysis of all the interactions existing in the final product, with Active Pharmaceutical Ingredients, excipients, coating (if applicable) and packaging material, promoting tests with samples both in stability time (tn) (tn) and initial time only (t0).

For the preliminary study, only samples with a t0 t0 stability time.[top]

[/fusion_text][fusion_menu_anchor name=”metodoscompatibilidade” class=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

[fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”#1a80b6″ top_margin=”” bottom_margin=”” border_size=”3″ icon=”” icon_circle=”” icon_circle_color=”” width=”32%” alignment=”left” /]

TECHNIQUES USED

To prove the drug efficacy and stability, tests must be carried out in conditions of temperature and humidity that accurately simulate those to which the finished product will be exposed throughout its shelf life.[top]

Techniques usually used:

  • Differential Scanning Calorimetry (DSC);
  • Thermogravimetric Analysis (TGA);
  • X-Ray Diffraction by Polycrystalline Materials (XRDp).

Depending on the need for each substance, the protocol may undergo changes leading to the study's optimization.

Fulfilling requirement? Talk to our experts.

[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_3″ layout=”1_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_image_id=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_size=”0″ border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”no”][fusion_separator style_type=”shadow” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_widget_area name=”avada-custom-sidebar-menu-servios12″ title_size=”” title_color=”” background_color=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””] [/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]