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Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion

Hot melt extrusion (HME) is a common formulation technology for amorphous solid dispersions (ASD) with advantages such as continuity, high production efficiency, low energy consumption, and environmental friendliness. It can meet the formulation requirements of various poorly soluble drugs. Hot melt extrusion utilizes a screw extruder to fully mix the API and polymer carrier in a molten state under the action of heat and mechanical stress, and extrude and cool down to form an amorphous solid dispersion.


Hot melt extrusion is a one-step manufacturing process that does not require solvents, but introduces mechanical stress, especially high shear forces. The process combines principles of mechanics, thermodynamics, rheology, and materials science. Due to the viscoelasticity of polymer materials and the thermal stability of the API and carrier, the design and control of the extrusion process are also very complex, including feed design, screw specifications and combinations, residence time distribution (RTD), and types of exit molds. In addition, downstream processes such as cooling, grinding, and tablet coating have a significant impact on product stability and bioavailability.



crystalpharmatech-2023913-85.pngHot melt extrusion process


Advantages vs. Disadvantages


Advantages



Disadvantages



Market oral formulations utilizing hot melt extrusion technology

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Case Study:


Olaparib

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Olaparib Compound Structure


Olaparib is the first FDA-approved oral poly (ADP-ribose) polymerase (PARP) inhibitor drug, which targets the DNA damage repair pathway and uses "synthetic lethality" to kill cancer cells without affecting healthy cells. It has been approved for multiple indications such as ovarian cancer, breast cancer, prostate cancer, and pancreatic cancer. With its excellent therapeutic effects, the drug has been marketed in over 90 countries worldwide, with global sales reaching $3.7 billion in 2022.


Although the drug has become a blockbuster in the field of oncology, during the development process, due to its low bioavailability, the original research attempted various dosage forms and formulation strategies before achieving successful commercialization.


Olaparib is a BCS class IV drug and a weakly acidic compound. It is basically neutral within the physiological pH range and has a low solubility in aqueous buffers (approximately 0.1 mg/mL over the pH range of 1-9). In simulated gastric and intestinal fluids, the solubility ranges from 0.12 to 0.20 mg/mL, with the highest solubility observed in postprandial simulated intestinal fluid at 0.20 mg/mL. The low solubility and permeability of the drug limit its bioavailability and clinical use.


To address the issues mentioned above, during the early development phase, the research team studied tablet and capsule formulations for the semi-solid glycerol monolaurate (LMG). In preclinical studies with dogs, it was found that the capsule formulation had better relative bioavailability. Initially, the formulation development focused on two methods to enhance the bioavailability of this poorly soluble compound: liquid-filled capsules and crystalline solid dispersion capsules. Due to the inability to find suitable solvent systems and considering potential issues such as capsule leakage, stability, and interactions between excipients and the active substance in liquid-filled capsules, the decision was made to develop crystalline solid dispersion capsules.


To increase the drug's exposed surface area, the research team adopted a micronization strategy for the active pharmaceutical ingredient (API). Despite the formulation optimization, the percentage of the active substance remained low.


Considering the capsule dosage form, patients needed to take eight capsules each time (50 mg specification, twice a day, totaling 400 mg each time). This dosing regimen was not ideal for patients. To reduce the burden on patients, the research team adjusted the drug dosage form again. Initially, they attempted to develop standard immediate-release tablets using micronized olaparib. However, even with micronized olaparib, the dissolution rate of this type of dosage form remained limited.


Since olaparib has low solubility in aqueous media (≤0.1 mg/mL), the development direction for the dosage form was to improve solubility. Subsequently, through systematic studies of several different enhanced formulations, it was found that the amorphous solid dispersion of olaparib prepared by hot-melt extrusion (HME) significantly improved bioavailability compared to other formulations (i.e., using glycerol monolaurate (LMG) capsule formulations). The amorphous solid dispersion formed by the active ingredient and the polymer carrier not only increased the loading of the active substance in a single dosage unit, reducing the number of doses (changed to twice a day, 300 mg each time, i.e., 2 tablets), but also significantly improved the drug's solubility and bioavailability. This resulted in a lower daily dose of the active ingredient in tablet form compared to the capsule formulation, with the 300 mg tablet achieving exposure levels equivalent to the original marketed capsule (which contained a significant amount of surfactant). This significantly improved patient compliance and marked a product upgrade.


Advantages of Crystal Pharmaceutical's HME


Crystal's Pharmaceutical CDMO division boasts a core team with backgrounds in polymer materials, chemical engineering, and mechanical engineering. Guided by the principles of rheology and engineering, our team has extensive expertise in the field of HME. We have previously developed HME-based formulation technology platforms, including immediate-release and sustained-release formulations, with a wealth of experience in process scale-up and commercial production. We have world-class equipment and analytical instruments for rheological research, formulation screening, and process development, from small-scale trials to commercial production. We sincerely hope to assist innovative pharmaceutical clients in overcoming the barriers posed by poorly soluble drugs using the hot-melt extrusion method.

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Solid Form Screening Solid Form Developability Evaluation Absolute Structure Determination Crystallization Process Development The Purpose Behind Molecules to Medicine Repurposing Dexmedetomidine into an Oral Sleep-Enhancing Medication The Role of Collaboration in Optimizing the Development of HIF Inhibitors for the Treatment of Advan Mol2Med™ Integrated Services AAPS 2024 PHarmSCi 360 Concerned about mRNA -LNP Integrity during International Shipping? Improving the Manufacture of mRNA Biologics Home Formulation Development Solid Form Screening and Selection Our Company Talent Recruitment Case Study 1: Indinavir - Early Salt Form Change The Tiny-TIM System Technical Articles Solid Form Research Engineering Cocrystal Solubility and Streamlining Cocrystal Early Development The Use of Amorphous Solid Dispersions to Enhance Dissolution, and Oral Bioavailability of Poorly Water-Soluble Pharmaceutical C Biologics CMC Analytical Services High-Resolution Mass Spectrometry Crystal Pharmatech Formulation Forum News & Events Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes Unlocking the Power of AI in Pharmaceutical Development Formulation & Delivery US 2024 Concerned about mRNA -LNP Integrity during International Shipping? Analytical Techniques to Assess the mRNA 5' Cap Small Molecule Solid-State Characterization/FAST Conventional Oral Solid Dosage Forms Our History News Our Business Case Study 2: DPC 961 – Form Change On A Fast Track Compound Detecting and Avoiding Disappearing Polymorph Cases by Crystal Structure Prediction Presentations Preclinical and Tox Formulation Development Synthonic Engineering: Tools for the Rational Design of High Quality Pharmaceuticals Polymorphism of Drugs - Can We Exploit Physical Form in the Development of Low Solubility Molecules? Bioanalysis and Biomarker Services 2023-Mol2Med™ First-Time-Right Approach Webinar Series Date: 2:00-3:00 pm EDT, Wednesday, Watch on-demand
Developability Assessment Oral Solid Dosage Forms Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying CATUG and Crystal Bio Establish Strategic Partnership, Launching “CATUG-Crystal” Joint Lab Dedicated to Advanced Nucleic Acid Analytical Services Characterization and Evaluation of Amorphous Solid Dispersion - Part 2 ADME Simulations: Insights into Bioavailability and Pharmacokinetics Utilizing Compaction Simulation for Advancing Oral Dosage Formulation Design Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality The 16th Drug Discovery Strategic Summit (DDSS) - San Francisco Bioanalytical and Biomarker Services Single Crystal Growth & Structure Determination Bioavailability Enhancement for Insoluble Compounds & PROTAC & Oral Peptides Our People Events Case Study 3: Atorvastatin - Crystalline Form Change In Late Development Selecting the Right API Form and Formulation Instrumentation for Electron Diffraction, Applications, and Case Studies Case Studies Effective Development of API Crystallization Processes During Drug Development Efficient Preclinical Formulation Development for Poorly Soluble Compounds pKa/LogP/LogD Measurements Date: 2:00-3:00 pm EDT, Wednesday, Watch on-demand
Amorphous Solid Dispersion (Spray Drying & Hot-melt Extrusion) Dr. LianFeng Huang Joins Crystal Pharmatech as Chief Scientist Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Characterization and Evaluation of Amorphous Solid Dispersion-Part 2 Parameter Sensitivity with GastroPlus Critical Quality Attribute D0 Impact in ADC Modality SAPA Annual Conference (Gold Corporate Sponsorship) Crystal Bio Solutions Bio Analytics API Form and Solid-State Research Crystallization Development Mini-tablet Knowledge Hub Molecules-to-Medicine: Accelerating Drug Development through Collaboration PBPK in Preclinical/FIH Scenarios Whitepaper Case Study 4: Gatifloxacin - Crystalline Form Changes With A Licensed Compound Amorphous Solid Dispersions Using Thermodynamic Phase Maps in API Crystallization Process Design Pre-clinical Formulation Strategies Sponsored by Crystal Pharmatech Date: 2:00-3:00 pm EDT, Wednesday, Whatch on-demand
Stability and Solubility Studies Comprehensive Physicochemical Property Evaluation Pediatric Formulation (Mini-tablet) Crystal Formulation Services successfully passed the dual certification of GMP and GDP conducted by SGS Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Assessment of CQA in mRNA-LNP Modality Overcoming Bioavailability Barrier to Deliver Protein Degraders 14th American Drug Delivery and Formulation Summit (Exhibit) Developability Assessment, Pre-formulation Study for IND Enabling Product Quality Analysis Additional Capabilities Chiral Separation Technology Our Partner Advanced Characterization: Tools for Accelerating Molecules to Medicine Tools for Accessing New Solid Forms Case Study 5: Lifecycle Management - Olanzapine - Crystalline Change From Free Acid to Salt Enabling Poorly Soluble Weak Bases for Improved Bioavailability: Why a Salt May Not be the Best Choice Integrated Phase and Formulation Selection to Support GLP Toxicology and First in Human Studies Sponsored by Crystal Pharmatech In-Silico PBPK Modeling and Simulation Industry Shift: FDA Goes Vegan? Date: 2:00-3:00 pm EDT, Wednesday,Watch on-demand
Crystallization Development Services Excipient Selection and Compatibility Studies Analytical Chemistry ASD Series Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying Overcoming Poor Solubility and Dissolution of Insoluble Molecules Patent Analysis of Resmetirom Sterility Assays in Drug/Device Manufacturing 2024 CASSS - Mass Spec Symposium Flow Cytometry About Us Pre-formulation Studies Formulations for PK/Efficacy/Tox Studies Crystallization and Spray Drying Process Development, Scale-Up, and Technology Transfer Case Study 6: Oxybutynin- Crystalline Change From Salt to Free Base Learn about Drug Eutectic Screening Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services Received China Drug Product Manufacturing License, Achieving the Important Milestone in Formulation Capability Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Biologics ChemOutsourcing 2024 Crystal Bio Webinar ELISpot Assays Solid-State NMR Analysis Resources Avoiding Drug Failures: Right First Time; Fast First Time Exploring the Pharmaceutical Solid State by Molecular Simulation Crystallization Process Method SMART Development of Pre-clinical Candidates Crystal Pharmatech Recognized as "Best Partner" by Allorion Therapeutics for Excellent Services Formulation and Analytical Development Animal Dosing Vehicle Selection Detecting Low-Level Crystallinity in ASD-like Samples Using ssNMR Techniques Understand ASD Manufacturing Strategies, Choose the Optimal One Immuno-Oncology Summit 2024 - Meet Crystal Bio at Booth 15 Molecular Biology Clinical and Commercial Manufacturing Amorphous Solid Dispersions Careers Tools and Strategies for De-risking Rapid Drug Substance and Drug Product Development API Crystallization Crystal Pharmatech Returned to AAPS 2022 PharmSci 360 Fun Sharing: The Secret Behind the Silky Smoothness of Chocolate (Part 2) GMP Manufacturing A Brief Introdction to Amorphous Solid Dispersion Technology Amorphous Solid Dispersions: Two Heads Are Better Than One FIH-PMF-FMF Manufacturing The Bioprocessing Summit 2024 - Meet Crystal Bio at Booth T13 Contact Us Crystal Pharmatech and Particle Sciences Form a US-China Pharmaceutical CRO Partnership Advancements in Analytical Tools for API and DP Characterization Co-crystals Fun Sharing: The Secret behind the Silky Smooth Enjoyment of Chocolate (Part 3) Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Meet Crystal Pharmatech at 2024 Controlled & Modified Drug Release Summit Assessment of Powder Segregation in Direct Compression (DC) Blends: Developing Predictive and PAT Tools Search Result Webinar Series Crystal Pharmatech Raises $10 Million to Accelerate Growth Solid Forms: The Good; The Bad; The Ugly Impact of Solid-state in Early Development Fun Sharing: The Secret Behind the Silkiness of Chocolate (Part 1) Join Crystal Pharmatech for the Sino-American Pharmaceutical Professionals Association (SAPA) NE 26th Annual Conference Formulation Design and Development of Fixed Dose Combination Solid Oral Dosage Forms Sitemap Crystal Formulation Services, Formulation Tailor-made for Your Molecules Utility of Single Crystal in Form and Formulation Selection Optimal Preclinical Formulation Development ​Crystal Pharmatech will be in San Diego from June 3-6 at BIO International Convention Drug Delivery and Patient Centric Approaches to Drug Development  404 Candoo Enables the Successful Development of a BCS 4 Combo Drug Product Introduction to MicroED Technology and Solutions Salts Fun Sharing:The Story Between Ice Crystals and Frozen Foods (Part 3) Meet Crystal Pharmatech at Chinese Antibody Society 2024 Annual Conference Privacy Policy International Company Crystal Pharmatech Finds CCIT An Optimal Spot for First US Location Formulation Implications Pharmaceutical Solid-state Forms Meet Crystal Pharmatech at 15th Drug Discovery Strategic Summit (DDSS) Submission Successful! Crystal Pharmatech Triples Headquarters in Biobay, China, with More Floors and Labs Fun Sharing: The Relationship Between Ice Crystals and Frozen Foods (Part 1) Clinical Supply Meet Crystal Pharmatech at Sorption Symposium North America 2024 Taggg Xceleron and Crystal Pharmatech Announce Partnership to Improve Early Clinical Development Utilizing Absolute Bioavailability Trials and Solid-State Solutions CPHI North America - Meet Crystal Pharmatech at Booth 1441 Search Result Service Crystal Pharmatech Introduces Customized Service Packages for Customers Seeking Materials Science Approaches in Drug Discovery and Development Fun Sharing: The Story of Ice Crystals and Frozen Foods (Part 2) Meet Crystal Pharmatech at MIDD+ Boston 2024 Search Result Others Crystal Pharmatech Expands Leadership Team Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion Formulation Development: Fastest-to-FIH Without Sacrificing Quality Crystal Formulation Services(CFS)Opens New Formulation Development Center and Analytical R&D Lab in Suzhou, China event page Development and Production Application Case Study of Amorphous Solid Dispersions: Spray Drying DCAT WEEK: CMC Discussions Amorphous Solid Dispersion Technology and the Service Advantages of Crystal Pharmaceutical AAPS PharmSci360 - Meet Us at Booth # 2106 Candoo's Formulation Technology Platform Featured in the Drug Development & Delivery Journal ASD Column | Mastering Stable Art: Unveiling Key Factors Influencing Physical Stability of Amorphous Solid Dispersions Meet the Crystal Pharmatech formulation team next week at CPHI Crystal Pharmatech and the Future of Pharma at AAPS PharmSci 360 Crystal Formulation Services' GMP Manufacturing Facility Successfully Passes the Remote Audit by US Client, Marking a Key Milestone for Its International Expansion ASD Column | How to Select Polymers in Hot-melt Extrusion Process? Crystal Pharmatech Raring to Go to ChemOutsourcing 2022 ASD Column | Understanding the ASD Preparation Methods and Selecting the Optimal Method for Solution Crystal Bio Welcomes Dr. Shiaw-Lin (Billy) Wu as Co-Founder and Chief Scientific Officer CPHI North america - Meet Us at Booth #530 Polymorphs, Solvatomorphs and Hydrate of Dabrafenib Crystal Bio Appoints Dr. Ye Gu as Co-founder, CTO, and Head of USA BD Shining Glory: Unveiling the "True Eye" behind the Veil of Drug Crystal Forms Crystal Pharmatech's CDMO Business Unit - Crystal Formulations Services Successfully Passed EU QP Audit Applications of Dynamic Moisture Adsorption in Crystal Research Meet Crystal Pharmatech at AAPS National Biotechnology Conference Application of Granularity Analysis in Crystal Typing Research Assessment of CQA in mRNA-LNP Modality DCAT Week 2025 A Brief Introduction to Amorphous Solid Dispersion Technology ADME Simulations: Insights into Bioavailability and Pharmacokinetics 19th WRIB (Workshops on Recent Issues in Bioanalysis)  Understand ASD Manufacturing Strategies, Choose the Optimal One Parameter Sensitivity with GastroPlus Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes
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bd_global@crystalpharmatech.com +1-609-604-8303