{"id":6216,"date":"2025-05-13T10:54:26","date_gmt":"2025-05-13T08:54:26","guid":{"rendered":"https:\/\/www.solids-development.com\/?p=6216"},"modified":"2025-05-13T11:06:16","modified_gmt":"2025-05-13T09:06:16","slug":"customer-credentials-stability-issues-in-tablet-production","status":"publish","type":"post","link":"https:\/\/www.solids-development.com\/en\/customer-credentials-stability-issues-in-tablet-production\/","title":{"rendered":"Customer Credentials \u2013 Stability issues in tablet production"},"content":{"rendered":"[et_pb_section fb_built=&#8220;1&#8243; admin_label=&#8220;section&#8220; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;0px|||||&#8220; global_colors_info=&#8220;{}&#8220; theme_builder_area=&#8220;post_content&#8220;][et_pb_row admin_label=&#8220;row&#8220; _builder_version=&#8220;4.16&#8243; background_size=&#8220;initial&#8220; background_position=&#8220;top_left&#8220; background_repeat=&#8220;repeat&#8220; custom_padding=&#8220;5px|||||&#8220; global_colors_info=&#8220;{}&#8220; theme_builder_area=&#8220;post_content&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;|||&#8220; global_colors_info=&#8220;{}&#8220; custom_padding__hover=&#8220;|||&#8220; theme_builder_area=&#8220;post_content&#8220;][et_pb_text admin_label=&#8220;Text&#8220; _builder_version=&#8220;4.21.0&#8243; background_size=&#8220;initial&#8220; background_position=&#8220;top_left&#8220; background_repeat=&#8220;repeat&#8220; global_colors_info=&#8220;{}&#8220; theme_builder_area=&#8220;post_content&#8220;]<p><strong><span>Customer Credentials \u2013 Stability issues in tablet production<\/span><\/strong><\/p>\n<p><strong><span>Situation at first contact<\/span><\/strong><\/p>\n<p><span>An international pharmaceutical company contacted us because they had stability issues with an important product. So far the produced tablet batches were still in-spec, but getting closer to the limits. To identify the root cause and find a solution, we were asked to set up an approach and action plan.<\/span><\/p>\n<p><strong style=\"font-size: 14px;\">Our Approach<\/strong><\/p>\n<p><strong><span>Step 1 \u2013 Understanding the situation and preparing an action plan<\/span><\/strong><\/p>\n<p><span>At the beginning, we had several meetings with the customer to understand the situation. We discussed the limits for finding solutions by changing ingredients or adapting the current FBG process, e.g. to dry granulation. During those meeting we already evaluated initial ideas on cause and possible solutions. At the end of this first step, we developed a comprehensive concept containing several work packages. The first work packages focused on the identification of the root cause.<\/span><\/p>\n<p><strong style=\"font-size: 14px;\">Step 2 \u2013 Understanding the root cause<\/strong><\/p>\n<p><span>The results of the first work package showed clearly that the root cause was related to moisture. Based on this finding, we updated our approach for the next work packages and started investigating the process. We performed several trials at a controlled relative humidity of 10 &#8211; 15%. For example, we analyzed the moisture within the ingredients themselves and also tested the impact of drying the ingredients before processing. We also divided the FBG process into a multi step process in order to better control the humidification of the critical ingredient.<\/span><\/p>\n<p><strong style=\"font-size: 14px;\">Results<\/strong><\/p>\n<p><span>We could define an adapted process to produce stable granules already before finalizing all planed trials. To save time and money, the process was verified by a final technical stability test in our lab. This allowed the customer to adapt his process in production scale.<\/span><\/p>\n<p><span>Finally, it was possible to find a solution for the current production process. A change to a completely different production process like dry granulation or bi-layer tableting was not necessary. <\/span><\/p>\n<p><span style=\"font-size: 14px;\">Do you face similar challenges and need support?<\/span><\/p>\n<p><span style=\"font-size: 14px;\">Let\u2019s talk about your formulation goals and how we can help you get there.<\/span><\/p>\n<p style=\"font-weight: 400;\"><span>Contact us (<a href=\"http:\/\/www.solids-development.com\/en\/\">www.solids-development.com<\/a>) or email us at contact@solids-development.com.<\/span><\/p>\n<p style=\"font-weight: 400;\"><span>\u00a0<\/span><\/p>\n<p><span><\/span><\/p>\n<p>&nbsp;<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]","protected":false},"excerpt":{"rendered":"<p>Customer Credentials \u2013 Stability issues in tablet production Situation at first contact An international pharmaceutical company contacted us because they had stability issues with an important product. So far the produced tablet batches were still in-spec, but getting closer to the limits. To identify the root cause and find a solution, we were asked to [&hellip;]<\/p>","protected":false},"author":8,"featured_media":6215,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[26],"tags":[],"class_list":["post-6216","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.1 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Customer Credentials \u2013 Stability issues in tablet production - Solids Development<\/title>\n<meta name=\"description\" content=\"Learn how we solved tablet production stability issues through moisture analysis and process optimization.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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