Ada Song’s Post

𝗥𝗼𝗹𝗲 𝗼𝗳 𝗿𝗵𝗲𝗼𝗹𝗼𝗴𝘆 𝗶𝗻 𝗳𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝗱𝗲𝘀𝗶𝗴𝗻 𝗼𝗳 𝗵𝗼𝘁 𝗺𝗲𝗹𝘁 𝗲𝘅𝘁𝗿𝘂𝗱𝗲𝗱 𝗮𝗺𝗼𝗿𝗽𝗵𝗼𝘂𝘀 𝘀𝗼𝗹𝗶𝗱 𝗱𝗶𝘀𝗽𝗲𝗿𝘀𝗶𝗼𝗻𝘀 Hot melt extrusion (HME) has been widely used as a continuous and highly flexible pharmaceutical manufacturing process for the production of a variety of dosage forms. In particular, HME enables preparation of amorphous solid dispersions (ASDs) which can improve bioavailability of poorly water-soluble drugs. The rheological properties of drug-polymer mixtures can significantly influence the processability of drug formulations via HME and eventually the end-use product properties such as physical stability and drug release. The objective of this review is to provide an overview of various rheological techniques and properties that can be used to evaluate the flow behavior and processability of the drug-polymer mixtures as well as formulation characteristics such as drug-polymer interactions, miscibility/solubility, and plasticization to improve the HME processability. An overview of the thermodynamics and kinetics of ASD processing by HME is also provided, as well as aspects of scale-up and process modeling, highlighting rheological properties on formulation design and process development. Overall, this review provides valuable insights into critical rheological properties which can be used as a predictive tool to optimize the HME processing conditions. #HotMeltExtrusion #HME #pharmaceutical

𝗔 𝗠𝗲𝘁𝗵𝗼𝗱 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗧𝗲𝗻𝘀𝗶𝗹𝗲 𝗦𝘁𝗿𝗲𝗻𝗴𝘁𝗵 𝗣𝗿𝗲𝗱𝗶𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗧𝗮𝗯𝗹𝗲𝘁𝘀 𝘄𝗶𝘁𝗵 𝗗𝗶𝗳𝗳𝗲𝗿𝗶𝗻𝗴 𝗣𝗼𝘄𝗱𝗲𝗿 𝗣𝗹𝗮𝘀𝘁𝗶𝗰𝗶𝘁𝗶𝗲𝘀 Tablets are the most commonly used dosage form in the pharmaceutical industry, and their properties such as disintegration, dissolution, and portability are influenced by their strength. However, in industry, the mixing fraction of powders to obtain a tablet compact with sufficient strength is determined based on empirical rules. Therefore, a method for predicting tablet strength based on the properties of a single material is required. The objective of this study was to quantitatively evaluate the relationship between the compression properties and tablet strength of powder mixtures. The compression properties of the powder mixtures with different plasticities were evaluated based on the force-displacement curves obtained from the powder compression tests. Heckel and compression energy analyses were performed to evaluate compression properties.  #excipient #Ceolus by Ceolus™ and Celphere™: Asahi Kasei Microcrystalline Cellulose Products

𝗘𝘅𝗽𝗹𝗼𝗿𝗶𝗻𝗴 𝗜𝗺𝗺𝗲𝗿𝘀𝗶𝗼𝗻 𝗖𝗼𝗮𝘁𝗶𝗻𝗴 𝗮𝘀 𝗮 𝗖𝗼𝘀𝘁-𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗠𝗲𝘁𝗵𝗼𝗱 𝗳𝗼𝗿 𝗦𝗺𝗮𝗹𝗹-𝗦𝗰𝗮𝗹𝗲 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗘𝗻𝘁𝗲𝗿𝗶𝗰-𝗖𝗼𝗮𝘁𝗲𝗱 𝗚𝗲𝗹𝗮𝘁𝗶𝗻 𝗖𝗮𝗽𝘀𝘂𝗹𝗲𝘀 💊 The coating process for solid dosage forms is widely used in the pharmaceutical industry but presents challenges for small-scale production, needed in personalized medicine and clinical or galenic settings. This study aimed to evaluate immersion coating, a cost-effective small-scale method, for enteric-coated gelatin capsules using standard equipment. Two enteric coating polymers and different polymer concentrations were tested, along with API solubility. Results were compared with commercially available enteric capsule shells. Successful preparation of enteric coating capsules via immersion necessitates a comprehensive grasp of API and enteric polymer behavior. However, utilizing commercially available enteric capsule shells does not guarantee ease or robustness, as their efficacy hinges on the attributes of the active ingredient and excipients. Notably, coating with Eudragit S100 stands out for its superior process robustness, requiring minimal or no development time, thus representing the best option for small-scale enteric capsule production. Learn more here: https://lnkd.in/e2MVHBfp #excipients #coating #drugdelivery

𝗧𝗵𝗲 𝗲𝗳𝗳𝗲𝗰𝘁 𝗼𝗳 𝗴𝗹𝗶𝗱𝗮𝗻𝘁 𝗼𝗻 𝘁𝗵𝗲 𝘁𝗮𝗯𝗹𝗲𝘁𝘁𝗶𝗻𝗴 𝗯𝗲𝗵𝗮𝘃𝗶𝗼𝗿 𝗼𝗳 𝗰𝗼𝗺𝗺𝗼𝗻 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗲𝘅𝗰𝗶𝗽𝗶𝗲𝗻𝘁𝘀 Glidant used for the purpose of powder flowability enhancement is well known within the pharmaceutical industry to improve tablet manufacturing. Despite the widespread use of glidant for this purpose, the effect of glidant on the effect of tableting behavior is not well studied. To address this deficiency, the effect on glidant on the tabletting behavior of seven common excipients was investigated. Tabletability, compressibility, compactability, and tablet expansion were studied. It was shown that glidant increased the tabletability for excipients known to exhibit plastic behavior. Based on compressibility and compactability, it was inferred that an increase in total bonding strength due to the presence of glidant was responsible for the improvement in tabletability. Results suggest this may be due to an increase in inter-particle bonding area. Conversely, glidants did not affect the tabletability of brittle excipients. The effect of glidant on die-fill bulk density was also studied to examine the impact associated with air entrapment and tablet expansion. While glidant significantly increased the die-fill powder density, this did not have an observable effect on tablet expansion or any other tabletting behavior examined. Continue reading here: https://lnkd.in/eBi6Pn_9 #excipients #pharmaceuticals #glidant

UPTON Sealing Test | Pharmaceutical Packaging Sealing Integrity Solution [Testing object] There are many drugs that need to be tested for packaging sealing in the pharmaceutical industry. The common ones include the following three categories: Sealed containers: vials, ampoules, syringes, oral liquids, sterile bags, infusion bags/bottles, water injections, powder injections, BFS bottles, API bottles, BPC bottles, FFS bottles and other closed containers. Blister packaging: samples of powders, tablets, capsules, contact lenses, etc. that are packaged in blister packaging. Small headspace packaging: granules packaging, small-dose pharmaceutical powders and other packaging with extremely small headspace. [Testing plan] In order to solve customers' problems, Shangteng Technology provides mature pharmaceutical packaging sealing integrity solutions. Option 1: Use a new generation of M90 pharmaceutical packaging leak tester from UPTON Technology, which can be applied to various types of packaging. In addition, the instrument is simple and fast to operate, and the results are reliable. [Instrument features] 1. The M90 pharmaceutical packaging sealing tester conducts qualitative and quantitative analysis of the sealing integrity of the packaging by precisely measuring the pressure or flow of air molecules escaping from defects in pharmaceutical packaging. It is an advanced high-precision non-destructive testing method. 2. The M90 is based on the core scientific and technological achievements accumulated in the early stage and is specially optimized for high-precision inspection of pharmaceutical packaging. The M90 is made of a lightweight and strong aluminum alloy shell, reaching the IP63 protection level and has excellent anti-electromagnetic interference capabilities. 3. The high-performance embedded Linux system supports advanced command interaction and operates stably. M90 takes into account both desktop use and automation cabinet integration. The core components of M90 are all independently developed. The special control valve we invented uses pneumatic control energy, which greatly reduces the heat interference of traditional electric-driven valves. Option 2: Use S20 sealing leak detector of UPTON Technology, with a testing aperture of 2μm (micron). Air tightness test standard unit, screen and machine separation [Instrument features] 1. Air leak test standard unit, screen and machine separation 2. Modular appearance design, convenient for centralized installation 3. Pressure range covers -100kPa to 2000kPa (2MPa) 4. Suitable for standardized large-volume testing, and can control multiple instruments to work simultaneously through the host computer

Tablet Press Machines in Pharmaceutical Manufacturing: Enhancing Production Efficiency in South Africa In the bustling pharmaceutical manufacturing industry of South Africa, tablet press machines stand as indispensable workhorses. These machines play a pivotal role in the production of tablets, ensuring precision, efficiency, and compliance with stringent quality standards. This blog post explores the significance, functionality, and benefits of tablet press machines in South Africa’s pharmaceutical sector, while highlighting how EquipmentTrader serves as a premier platform for original equipment manufacturers (OEMs) to showcase and advertise their advanced equipment solutions. Understanding Tablet Press Machines Tablet press machines are mechanical devices designed to compress powdered or granular substances into tablets of uniform size, shape, and weight. They operate on the principle of applying high pressure to the material within a die cavity, forming tablets that meet pharmaceutical specifications. These machines are crucial for pharmaceutical companies, ensuring consistent dosage forms that are essential for patient safety and treatment efficacy. Key Components of Tablet Press Machines Hopper: Holds the raw material (powder or granules) to be compressed into tablets. Die and Punches: Form the tablets by compressing the material within the die cavity. Compression Mechanism: Applies the necessary force to form tablets of uniform size and weight. Control System: Regulates parameters such as compression force, speed, and tablet thickness. Ejection Mechanism: Releases the formed tablets from the machine. Types of Tablet Press Machines Single Punch Tablet Press Ideal for small-scale production or laboratory settings, single punch tablet presses are manually operated and suitable for producing tablets in small batches for research and development purposes. Rotary Tablet Press Rotary tablet presses are high-speed machines capable of producing thousands of tablets per hour. They feature multiple punches and dies arranged in a rotating turret, maximizing efficiency in large-scale production. To read the full article, please visit: https://lnkd.in/d_5Yqvei

𝗙𝗹𝘂𝗶𝗱 𝗯𝗲𝗱 𝗴𝗿𝗮𝗻𝘂𝗹𝗮𝘁𝗶𝗼𝗻 – 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻 by Line Koleilat, Christian Paasche,Jonathan Wade, Joshua Hanson, Carl Wassgren and Paul Mort Fluidized bed granulation is a single unit operation that integrates several process transformations including powder transfer and fluidization, atomization of binder solution and wetting of the fluidized powder, growth and consolidation of granules, drying, and discharge of the granular product. Binder spray addition, drying enthalpy and fluidization parameters control the process. Balanced control of fluidization can be challenging in the context of micronized powders, prone to elutriation, for example as required in some pharmaceutical formulations. This paper explores the effects of thermodynamic and flow field parameters on the size and shape distributions of a challenging pharmaceutical formulation. Pre-wetting the powder mixture prior to fluidization effectively reduces elutriation, stabilizes the fluidization process, and results in narrower granule size distributions. Optimizing filter blowback pressure can further stabilize the process. These strategies contribute to improved control of fluidized bed granulation, particularly for challenging pharmaceutical formulations, enhancing both product quality and process efficiency. #fluidizedbed #granulation

𝗙𝗹𝘂𝗶𝗱 𝗯𝗲𝗱 𝗴𝗿𝗮𝗻𝘂𝗹𝗮𝘁𝗶𝗼𝗻 – 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻 Fluidized bed granulation is a single unit operation that integrates several process transformations including powder transfer and fluidization, atomization of binder solution and wetting of the fluidized powder, growth and consolidation of granules, drying, and discharge of the granular product. Binder spray addition, drying enthalpy and fluidization parameters control the process. Balanced control of fluidization can be challenging in the context of micronized powders, prone to elutriation, for example as required in some pharmaceutical formulations. This paper explores the effects of thermodynamic and flow field parameters on the size and shape distributions of a challenging pharmaceutical formulation. Pre-wetting the powder mixture prior to fluidization effectively reduces elutriation, stabilizes the fluidization process, and results in narrower granule size distributions. Optimizing filter blowback pressure can further stabilize the process. These strategies contribute to improved control of fluidized bed granulation, particularly for challenging pharmaceutical formulations, enhancing both product quality and process efficiency. Learn more: https://lnkd.in/edyjTHat

Improving dispensing of a nanoparticulate formulation in manufacturing Biotech Fluidics reports on the successful development and implementation of a pioneering combined micro flowmeter and degasser set-up to improve dispensing of a nanoparticulate formulation for a leading medical technology company. To ensure the accuracy of spray coating of the pharmaceutical formulation onto a medical device the CMO turned to Biotech Fluidics because of their experience in creating turnkey fluidics systems and expertise in degassing. #NanoparticleDispensing #ManufacturingInnovation #NanotechManufacturing #PrecisionDispensing #NanoparticleFormulation Biotech Fluidics https://lnkd.in/e4ttQttd

𝗖𝗼𝗺𝗽𝗮𝗿𝗮𝘁𝗶𝘃𝗲 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻𝘀 𝗼𝗳 𝗗𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝗖𝗼𝗺𝗽𝗿𝗲𝘀𝘀𝗲𝗱 𝘃𝗲𝗿𝘀𝘂𝘀 𝗔𝗱𝗱𝗶𝘁𝗶𝘃𝗲𝗹𝘆 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗱 𝗧𝗮𝗯𝗹𝗲𝘁𝘀 Selective laser sintering (SLS)-mediated additive manufacturing (AM) technology is increasingly being used for manufacturing pharmaceutical solid oral dosage forms (SODFs) due to its advantages over other AM and conventional manufacturing (CM) methods. Direct compression (DC) has a competitive edge in CM due to ease of manufacturing, while both DC and SLS-mediated AM processes share similarities in manufacturing steps and usage of fewer excipients. There is a need for a comparative evaluation of the pharmaceutical performance of the prepared DC and SLS-mediated SODFs and the environmental impacts of both DC and SLS-mediated AM processes, which has yet to be addressed. #3Dprinting #SLS #directcompression