[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=”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=””]

PHARMACEUTICAL DEFORMULATION STUDY

[/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=”” id=””]

The Pharmaceutical Form Deformulation study is used to perform drug synthesis, and is part of the initial scope of manufacturing these products. Commonly applying the practice of reverse engineering, this analysis qualitatively and quantitatively refines the components of the reference product, obtaining detailed information on its formulation for later reproduction.

On generic drugs manufacturing, the reference product and the new drug must have the necessary interchangeability to be approved by the regulatory agency. This implies that it must be proven to be bioequivalent to the original product, resulting in the same active effect on the patient's body.

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

“Interchangeability, that is, the safe replacement of the reference drug by its generic, is ensured by therapeutic equivalence tests, which include in vitro comparison, by pharmaceutical equivalence, and in vivo studies, with the bioequivalence studies submitted to the Brazilian Health Regulatory Agency (ANVISA). ” Source: www.portal.anvisa.gov.br

Deformulation considers several aspects and chemical tests. Furthermore, the new drug must have the same polymorphic shape as the reference product to ensure the same stability and dissolution profile.

NanoBusiness offers the complete study of Pharmaceutical Form Deformulation, including the coverage of complex tests that require Synchrotron light.

[/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=””]

How can we can help?
Talk to our experts.
BUDGET

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