Customer Credentials:<\/b><\/p>\n
Informative feasibility study on dry granulation provides a reliable database for business case analysis <\/b><\/p>\n
Situation at first contact<\/b><\/p>\n
A medium-sized pharmaceutical company was planning some medium-term changes for one of its products. In this context, the question arose if a transfer from wet to dry granulation would be a profitable business case. They contacted us to perform a feasibility study and to develop a reliable prototype formulation, with which they could do their calculations.<\/p>\n
Our Approach<\/b><\/p>\n
Step 1 \u2013 Paperwork<\/b><\/p>\n
Before jumping into the development work, we started by analyzing the whole production process and by extracting the essential requirements. Additionally, we identified the crucial points in the formulation, e.g.\u00a0 excipients which needed to be exchanged, modified or even left out to achieve a robust dry granulation formulation. As no information about the dry granulation behavior of the formulation or the API was available, we suggested to characterize the API first and than proceed with two basis formulations that are still close to the actual formulation.<\/p>\n
Step 2 \u2013\u00a0 Formulation Work<\/b><\/p>\n
Although the pure API only showed moderate densification properties, the drug load and the other excipients allowed to compensate for it.\u00a0 Both basic formulations had good enough recompaction properties but one hat a clearly better dissolution profile. Mutual we agreed to optimize the latter concerning both, recompaction and dissolution behavior, and analyzed three more prototypes by using the small-scale method. For two of these three prototypes the requirements for being a dry granulation candidate were fulfilled.<\/p>\n
Results<\/b><\/p>\n
Based on our feasibility study, the company had the certainty that its product could also be manufactured by dry granulation. Thanks to the prototypes developed, it was now possible to carry out a sound business case calculation. The amount of API used was less than 100 g.<\/p>\n
Do you face similar challenges and need support? Take the next step today.<\/p>\n
We look forward to hearing from you.<\/span><\/p>\n <\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]","protected":false},"excerpt":{"rendered":" Customer Credentials: Informative feasibility study on dry granulation provides a reliable database for business case analysis Situation at first contact A medium-sized pharmaceutical company was planning some medium-term changes for one of its products. In this context, the question arose if a transfer from wet to dry granulation would be a profitable business case. They […]<\/p>","protected":false},"author":8,"featured_media":6115,"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":[341,38,338,336,43,340,343,337,82,44,344,342,339],"class_list":["post-6110","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-api-characterization-in-granulation","tag-arzneimittelentwicklung","tag-dry-granulation-feasibility-study","tag-feasibility-study-dry-granulation","tag-formulierungsentwicklung","tag-granulation-method-comparison","tag-granulierungsverfahren-pharma","tag-machbarkeitsstudie-trockenvergranulierung","tag-pharmaceutical-production","tag-solidsdevelopment","tag-trockenvergranulierung-prototyp-formulierung","tag-vergleich-nass-vs-trockenvergranulierung","tag-wet-vs-dry-granulation"],"yoast_head":"\n