Drug Digest: Focusing on Solid Dosage Trends and Demand
PharmaTech
DECEMBER 6, 2024
In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development and manufacturing.
Drug development trends: insight from Thermo Fisher’s Anil Kane
European Pharmaceutical Review
DECEMBER 1, 2023
During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?
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International regulation: the importance of quality assurance in drug development
European Pharmaceutical Review
JULY 4, 2023
As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are the main challenges quality assurance and compliance professionals face during the drug development and review process?
Drug Digest: Adapting to Solid Dosage Development and Manufacturing Needs
PharmaTech
DECEMBER 20, 2023
In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, chats about the trends shaping solid dosage drug development and manufacturing with Jan Vertommen from Lonza and Dave DiProspero from CRB Group.
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Collaboration to produce 3D screen printed pharmaceuticals
European Pharmaceutical Review
MARCH 22, 2023
The technology is an additive manufacturing process which enables the development and production of complex formulations and geometrical structures of oral dosage forms to optimise the release profiles of common pharmaceuticals in addition to new drug developments.
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Responsible sourcing and manufacturing: Growing towards a sustainable future with Lonza
Express Pharma
JANUARY 17, 2025
As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. Lonzas comprehensive sustainability approach spans the entire value chain, from raw material selection to end-of-life solutions.
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Optimize your drug development timeline with liquid-filled, hard-shell capsules
BioPharma Dive
JULY 17, 2023
With this highly marketable dosage form, scientists can effectively formulate poorly soluble drugs and supplements, while reducing development time and costs.
Aragen commissions new formulations manufacturing facility in Hyderabad
Express Pharma
OCTOBER 19, 2023
The company informed that it is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals, and films. We look forward to leveraging these capabilities to support our customers’ drug development needs, enabling them to bring life-changing medicines to patients worldwide.”
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CDMO acquires Meppel facility from Astellas
European Pharmaceutical Review
APRIL 9, 2024
The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The acquisition will strengthen the CDMO’s position in the Netherlands, where it already owns a manufacturing facility in Bladel and an injectable drug development centre in Leiden.
Flexible-Dosage Development Strategies for Today's Clinical Landscape
PharmaTech
JANUARY 7, 2025
This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. However, flexible dosing strategies are often neglected or not prioritized early in development.
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How using AI in clinical trials accelerates drug development
Pharmaceutical Technology
JUNE 15, 2023
Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.
First AI-generated small molecule drug enters Phase II trial
European Pharmaceutical Review
JUNE 29, 2023
Achievement of the first dose in human patients is a “milestone” for AI-driven drug discovery and drug development , stated Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine. In February 2021, the small molecule drug INS018_055 started a first-in-human study for IPF in November 2021.
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UK trial to test psilocin-based drug for major depressive disorder
European Pharmaceutical Review
JUNE 28, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.
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Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle
Quality Matters
MAY 17, 2023
Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.
Overcoming The Challenges Of Pediatric Formulation
PharmaTech
NOVEMBER 5, 2023
To help improve adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.
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Novel oral chemotherapeutic holds potential for stomach cancer patients
European Pharmaceutical Review
JULY 5, 2022
The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author.
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Indian biotech start-ups: Need for pragmatic, pro-active, progressive regulatory milieu
Express Pharma
AUGUST 10, 2024
Bio-entrepreneurs are interested in developing a diversity of new healthcare products based on new sources, new targets or new formulations. The clinical development and regulatory approval requirements would be different for each of these products.
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Overcoming The Challenges of Pediatric Formulation
PharmaTech
FEBRUARY 14, 2023
But to overcome the challenges of adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.
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Biopharmaceutical bioseparation systems market to value $20bn
European Pharmaceutical Review
JUNE 28, 2022
Chromatography can be used throughout the drug development process, from the identification od potential drug candidates (with HPLC enabling high throughput screening) to ensuring drug formulation purity, analysing the bioavailability and release time of novel drug formulations to determine dosages to devising manufacturing techniques.
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
European Pharmaceutical Review
FEBRUARY 14, 2024
It is well understood that drug substance shelf life is extended when the cells are maintained in a cryo-preserved state at –20°C or below. Tablet dosage forms are feasible but run the risk of losing cell viability during compression and exposure to solvent during direct coat application to the tablet surface may result in viable cell loss.
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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)
FDA Law Blog: Biosimilars
APRIL 2, 2024
This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”
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Leading pharmaceutical solid dose (commercial dose) manufacturing companies in contract marketing
Pharmaceutical Technology
SEPTEMBER 8, 2022
Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Growth of oral solid dosage contract manufacturing in the pharmaceutical industry.
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Connecting with Patients at Home
Pharmacy Is Right For Me
APRIL 4, 2023
There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! And when the medication was delivered to her home, she realized the dosage no longer matched her regimen. This patient received a 30-day supply of insulin before discharge.
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For neurological disease, solving measurement is the first and biggest hurdle to re-imagining treatment
pharmaphorum
JULY 13, 2022
The lack of measurability in neurological diseases plagues pharma every step of the way when it comes to drug development. Just recruiting for a trial of a drug that’s meant to intervene at an early stage of Parkinson’s or Alzheimer’s is difficult, because patients are almost never diagnosed until they’re symptomatic.
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WuXi STA opens its first oral solids continuous manufacturing line
European Pharmaceutical Review
JANUARY 4, 2023
WuXi STA , a subsidiary of WuXi AppTec, has announced that its first continuous manufacturing ( CM ) line for oral solids is in operation at its drug product site in Wuxi city, China. A report has estimated that the oral solid dosage (OSD) contract manufacturing market will be valued at $54.7 Oral solids. billion by 2030.
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Unlocking the Potential: The Power of Drug Repurposing in Modern Medicine
Syner-G
SEPTEMBER 20, 2023
By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization.
Roquette opens new pharma innovation center in US
Express Pharma
APRIL 19, 2023
With a focus on optimising patient experience with next-generation oral dosage forms, the US facility complements the cutting-edge research activities of Roquette’s existing pharma innovation centers in France and Singapore. Expert training, troubleshooting and scale-up advice will be priorities at the facility.
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Patents: a necessary evil?
European Pharmaceutical Review
OCTOBER 19, 2022
This is the practice of modifying the product, ie, changing the dosing interval from three times daily (tid) to once daily (od) using controlled release dosage forms immediately prior to generic entry into the market – but equally it could be argued also improving patient compliance. link] [Cited 25 September 2022]. 2022;12(7):3049-3062.
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Sandoz spin-off continues Novartis’ focus on innovation; $22bn purchase rumoured
Pharmaceutical Technology
SEPTEMBER 26, 2022
These highlight the parent company’s focus on innovative and high-value drug development. Novartis said in August that it intended to shut down its Sandoz oral solid dosage plant in Wilson, North Carolina, which provides tablets to Canada and the US, next year. The company had revenues of $9.6bn both in 2020 and last year.
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Personalized Medicine Requires a New Approach to Quality Control
Syner-G
JULY 7, 2023
It guarantees delivery of the right drug and the right dosage at precisely the right time , tailored specifically for that person. Drug developers must establish stable, robust, and cost-efficient manufacturing processes, especially for rare disorders with small patient populations and limited therapeutic options.
2022 spells change for EU pharmaceutical legislation
European Pharmaceutical Review
JUNE 24, 2022
But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.
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Solving pharma’s process development challenges one API at a time
Pharmaceutical Technology
AUGUST 3, 2022
The potential to use these scientific breakthroughs to make a real difference to patients’ lives is what drives many highly skilled scientists to the world of drug development. Yet commercialising a drug is no easy journey, hence why just 10% of new drug candidates succeed in making it to market.
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Leading commercial dose companies in contract marketing
Pharmaceutical Technology
SEPTEMBER 14, 2022
The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables. These companies offer services such as formulation development, process optimisation, analytical method development, qualification, validation and testing, regulatory guidance and several other solutions and products.
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How to Successfully Employ External Comparator Arm Studies Using Real World Data
pharmaphorum
OCTOBER 11, 2022
eligible dosages, how the drug is administered, and frequencies of drug intake). In the general case, RCTs are the optimal approach to clinical research and drug development. Various sophisticated methods are possible and sensitivity analyses should be applied to check on the robustness of results. Discussion.
Patient Engagement in Pharma – Why and How?
Viseven
AUGUST 15, 2024
The traditional model of drug development and healthcare delivery is undergoing a seismic shift, with patient engagement emerging as a critical factor in achieving better health outcomes and driving innovation. This change is further driven by major regulatory bodies emphasizing Patient-Focused Drug Development (PFDD).
Patient Centricity for Pharma Marketing – Quiz
PharmaState Academy
OCTOBER 20, 2023
a) It has no impact b) It improves medication taste c) It simplifies dosage instructions d) It provides discounts on medications 9 / 20 According to a study in the Journal of General Internal Medicine, what percentage of patients feel rushed during doctor's appointments?
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Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing
Pharmaceutical Technology
FEBRUARY 13, 2023
Given the plethora of new chemical entity (NCE) candidates, pharmaceutical research groups frequently face challenges when selecting the most promising candidate for development purposes. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?
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Mitigating fill, finish and CCI challenges for injectables
Express Pharma
MAY 10, 2023
However, this philosophy isn’t just relegated to guiding the practices of medical professionals and drug developers. It extends all the way down to the healthcare sector’s expectations for every component, instrument, and process orbiting the development and manufacture of medicine—especially parenteral drugs.
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PROTAC development gains momentum, but clinical performance is poor
Pharmaceutical Technology
FEBRUARY 13, 2023
This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.
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Ready, steady, scale: How to mitigate risks in process scale-up
Pharmaceutical Technology
JULY 18, 2022
Compaction simulation is arguably the most important when dealing with oral solid dosage forms. The single-punch tableting press enables drug developers to test formulations at full production speed, replicating the parameters of all types of industrial rotary press.
Thinking differently about excipient quality to ensure medicines supply chain resilience
Quality Matters
JUNE 6, 2023
Despite being called “inactive” ingredients, excipients in medicines play a vital role in drug development, delivery, effectiveness, and stability. Comprising up to 90% of individual drug products, excipients function as binders, disintegrants, solubilizers, coatings, preservatives, colors, and flavorings.
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How Pharmacists Can Use Artificial Intelligence To Advance Their Practice: Insights From ChatGPT
ID Stewardship
JUNE 6, 2023
Patient Education and Adherence : AI chatbots or virtual assistants can be developed to provide patients with on-demand information about their medications, dosages, potential side effects, and adherence strategies. This empowers patients to make informed decisions and fosters better medication adherence.
Top 20 Radiopharma Companies Based on Market Cap
PharmaShots
FEBRUARY 21, 2023
The company is developing PPMX-T002, an anti-cancer drug with an antibody targeting CDH3 connected with a radioisotope yttrium 90 (90Y). Perseus has been discussing the collaborative development of PPMX-T002 with various RI medical drug-developing companies, including PeptiDream and its subsidiary PDRAdhiopharma.
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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development
Pharmaceutical Technology
FEBRUARY 23, 2023
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
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