{"id":13178,"date":"2026-04-02T09:01:47","date_gmt":"2026-04-02T00:01:47","guid":{"rendered":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/?p=13178"},"modified":"2026-05-11T11:59:54","modified_gmt":"2026-05-11T02:59:54","slug":"%e5%88%9d%e6%9c%9f%e8%87%a8%e5%ba%8a%e3%81%a7%e8%b5%b7%e3%81%93%e3%82%8a%e3%81%8c%e3%81%a1%e3%81%aaapi%e4%b8%8d%e8%b6%b3%e3%83%bb%e5%8e%b3%e3%81%97%e3%81%84%e9%96%8b%e7%99%ba%e8%a8%88%e7%94%bb","status":"publish","type":"post","link":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/column\/p13178\/","title":{"rendered":"How We Overcame API Shortages and Tight Development Timelines in Early Clinical Stages \uff0d Xcelodose\u00ae Utilization Case Studies"},"content":{"rendered":"<p>These case studies showcase how, through the combination of the Xcelodose\u00ae system and SPERA PHARMA\u2019s expertise, we were able to meet project requirements even with limited API quantities and tight timelines.<\/p>\n<h4>Case Study 1: Projects Requiring High Yield\u00a0with Only a Limited Amount of API Available<\/h4>\n<p><strong>Request<\/strong><\/p>\n<ul>\n<li>Only a very small amount of API is available, but the required number of capsules must be secured.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Key Challenges<\/strong><\/p>\n<ul>\n<li>The amount of API available is already limited, making additional supply difficult.<\/li>\n<li>A yield of approximately 80% had been assumed for the project.<\/li>\n<li>Based on the available API quantity, achieving the required number of capsules would require a yield of 90%.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>SPERA PHARMA\u2019s Approach<\/strong><\/p>\n<ul>\n<li>Evaluation of powder characteristics: Observed the API\u2019s powder characteristics during in-bottle vibration tests and scooping operations.<\/li>\n<li>Dispensing head selection: Chose the most suitable dispensing head from dozens of hopper types based on the API\u2019s powder characteristics.<\/li>\n<li>Adjustment of vibration frequency: Tuned operating speed to achieve the target fill weight.<\/li>\n<li>Troubleshooting: Monitored for early signs of issues such as API clogging and capsule ejection abnormalities.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Outcome<\/strong><\/p>\n<ul>\n<li>Through various adjustments, we successfully secured the required number of capsules.<\/li>\n<li>By avoiding API re-synthesis or re-procurement, we were able to mitigate the risk of delays to the early clinical schedule.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h4>Case Study 2: Capsule Filling of an API with Low Flowability and a Strong Tendency to Accumulate Static Electricity<\/h4>\n<p><strong>Request<\/strong><\/p>\n<ul>\n<li>The client requested that mass-produce capsule fills using an API that is prone to static electricity.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Key Challenges<\/strong><\/p>\n<ul>\n<li>Because the API is highly prone to static electricity, it agglomerates inside the hopper, resulting in poor flowability and making machine filling difficult.<\/li>\n<li>Manual filling was estimated to require approximately nine months, which would not meet the clinical study timeline.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>SPERA PHARMA\u2019s Approach<\/strong><\/p>\n<ul>\n<li>Static Electricity countermeasures: Use of an ionizer<\/li>\n<li>Fundamental solution: Implementing a formulation adjustment that prevents the generation of static electricity.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Outcome<\/strong><\/p>\n<ul>\n<li>Improved the powder\u2019s flowability and achieved stable filling using the Xcelodose\u00ae.<\/li>\n<li>Completed manufacturing and delivery within one month.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>When to Consult SPERA PHARMA<\/strong><\/p>\n<p>If you face challenges like these, please feel free to consult us:<\/p>\n<ul>\n<li>You want to minimize development cost and timelines.<\/li>\n<li>The dosage (administered amount)\u00a0 is difficult to finalize.<\/li>\n<li>The clinical team is requesting a shorten formulation development timelines<\/li>\n<li>You aim to accelerate development \uff0d\u3000and proceed more quickly with clinical studies and evaluations \uff0dby reducing the number of tests required.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Contact<\/strong><br \/>\n<a href=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/inquiry\/\">https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/inquiry\/<\/a><br \/>\nBy sharing an overview of your API and target schedule, we can assess feasibility and provide an estimated lead time.<\/p>\n<h4>Reference: Operational Capabilities at SPERA PHARMA<\/h4>\n<ul>\n<li>Supported capsules: HPMC size 0 to 4 (extensive experience with sizes 0 and 3)<\/li>\n<li>Fill weight range: 1 mg to 100 mg<\/li>\n<li>Throughput: Up to 1,500 capsules\/day (depending on API properties)<\/li>\n<li>Weight control: Individual capsule weight recorded for all capsules (GMP-compliant)<\/li>\n<li>Number of systems: 2 units<\/li>\n<\/ul>\n<p>For further details, please visit<br \/>\nAPI Direct Capsule Filling Using Xcelodose\u00ae<br \/>\n<a href=\"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/technology\/formulation\/xcelodose\/\">https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/en\/technology\/formulation\/xcelodose\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>These case studies showcase how, through the combination of the Xcelodose\u00ae system and SPERA PHARMA\u2019s expertise [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_locale":"en_US","_original_post":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/?p=13052","footnotes":""},"categories":[5],"tags":[],"class_list":["post-13178","post","type-post","status-publish","format-standard","hentry","category-column","en-US"],"acf":[],"_links":{"self":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/13178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/comments?post=13178"}],"version-history":[{"count":20,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/13178\/revisions"}],"predecessor-version":[{"id":13327,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/posts\/13178\/revisions\/13327"}],"wp:attachment":[{"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/media?parent=13178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/categories?post=13178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/heuristic-ardinghelli.153-122-123-210.plesk.page\/wp-json\/wp\/v2\/tags?post=13178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}