Risk reduction in tablet dosage form development and manufacturingDipankar Dey
This article describes how measuring material properties that
relate directly to the final tablet product, including the inherent
ability of materials to form tablets (compressibility) reduces the
overall risk in tablet development and manufacture. A case
study illustrates the benefits of rapid compressibility assessment.
Risk reduction in tablet dosage form development and manufacturingDipankar Dey
This article describes how measuring material properties that
relate directly to the final tablet product, including the inherent
ability of materials to form tablets (compressibility) reduces the
overall risk in tablet development and manufacture. A case
study illustrates the benefits of rapid compressibility assessment.
Hot melt extrusion with PVA: A new opportunity for challenging APIs Merck Life Sciences
Access the interactive recording: https://bit.ly/2PSxDUj
Abstract:
Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance.
In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer.
We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends.
You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release.
Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications.
In this webinar, you will learn:
* about amorphous solid dispersions and their preparation by hot melt extrusion
* how to identify the right polymer at early development stages
* how to improve the performance of your formulation by using polyvinyl alcohol
Addressing Downstream Challenges with Complex InjectablesMerck Life Sciences
The complex injectable market is gaining traction in the injectable therapies, however manufacturing of it is critical. In this webinar, lets brainstorm on the downstream criticalities of these molecules and how to handle the same.
The principal objective of dosage form design is to
achieve a predictable therapeutic response to a drug
included in a formulation which is capable of large scale
manufacture with reproducible product quality. To ensure
product quality, numerous features are required, like
chemical and physical stability, suitable preservation
against microbial contamination if appropriate,
uniformity of dose of drug, acceptability to users
including prescriber and patient, as well as suitable
packing, labeling, and validation1
.
Process validation establishes the flexibility and
constraints in the manufacturing process controls in the
attainment of desirable attributes in the drug product
while preventing undesirable properties. This is an
important concept, since it serves to support the
underlying definition of validation, which is a systematic
approach to identifying, measuring, evaluating,
documenting, and re-evaluating a series of critical steps in
the manufacturing process that require control to ensure
a reproducible final product.3
USFDA defined process validation as “establishing
documented evidence which provides high degree of
assurance that a specific process will consistently produce
a product meeting its pre determined specifications and
quality characteristics.”5
Solid dosage forms include tablets and capsules. The
manufacturing of solid dosage forms involves extensive
powder handling. The powder must be blended for
uniformity and converted into the dosage form either
through compression or encapsulation. Typical
requirements include weighing, blending,
mixing/granulation areas, compression/encapsulation
areas, and coating areas. 2
Despite the ongoing development of more sophisticated
solid drug delivery systems, tablets are still by far the
most prevalent solid dosage form. The emphasis will be
on the practical inspectional requirement, rather than on
a theoretical approach that does not reflect the
practicalities (and problems) encountered when
validating actual production operations.
A tablet is a pharmaceutical dosage form. It comprises a
mixture of active substances and excipients, usually in
powder form, pressed or compacted into a solid. The
excipients can include binders, glidants (flow aids) and
lubricants to ensure efficient tabletting; disintegrants to
promote tablet break-up in the digestive tract;
sweeteners or flavors to enhance taste; and pigments to
make the tablets visually attractive. A polymer coating is
often applied to make the tablet smoother and easier to
swallow, to control the release rate of the active
ingredient, to make it more resistant to the environment
(extending its shelf life), or to enhance the tablet's
appearance
Addressing Raw Material Handling Challenges by Dry GranulationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2NXmi8O
Caking and clumping of pharmaceutical raw materials have a negative impact on manufacturing efficiency. Learn which benefits dry granulation provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
Buffers, salts and stabilizing chemicals are used in multi-ton quantities during pharmaceutical manufacturing. The handling of such quantities can be challenging: caking and clumping of chemicals, dust formation and laborious weighing have a negative impact on manufacturing efficiency and may even lead to process interruptions, quality deviations and operator safety risks. In many cases, these limitations can be overcome by granulated material.
Learn which benefits dry granulation by roller compaction provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
In this webinar, you will learn:
• Which effects clumping and caking of pharmaceutical raw materials can have on operations
• How dry granulation of raw materials can help overcome these issues
• Which technical and chemical parameters are key for a suitable granulation outcome
Webinar: How to Develop a Regulatory-compliant Continued Process Verificatio...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/CPVWebinar
Product life cycle consists of 3 phases: Process Design, Process Performance Qualification and the last and the lengthiest Continued Process Verification (CPV). As more and more biomanufacturing processes enter commercial phases, the critical need to understand how to efficiently perform CPV programs arises.
Explore our webinar library: www.emdmillipore.com/webinars
Key Considerations & Case Study for Building a cGMP Biomanufacturing FacilityMilliporeSigma
Every biopharma executive must make important decisions early in clinical development. One of these decisions includes defining the commercial manufacturing strategy for their biopharmaceutical and whether it makes business sense to build their own cGMP biomanufacturing facility. We have gained significant expertise throughout the design, build and ongoing operations of the Biodevelopment Center in Martillac, France that could prove invaluable to companies that are considering whether to build their own cGMP facility or outsource to a contract manufacturing organization. In this webinar, our experts share some key considerations for designing, building and operating an agile and flexible cGMP biomanufacturing facility successfully, safely, and profitably.
In this webinar, you will learn:
- How to design and build a flexible and agile facility
- The regulatory requirements for the facility
- How we have converted a stainless steel cGMP bioproduction facility in Martillac, France into a state-of-the-art, fully single-use cGMP facility
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Hot melt extrusion with PVA: A new opportunity for challenging APIs Merck Life Sciences
Access the interactive recording: https://bit.ly/2PSxDUj
Abstract:
Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance.
In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer.
We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends.
You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release.
Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications.
In this webinar, you will learn:
* about amorphous solid dispersions and their preparation by hot melt extrusion
* how to identify the right polymer at early development stages
* how to improve the performance of your formulation by using polyvinyl alcohol
Addressing Downstream Challenges with Complex InjectablesMerck Life Sciences
The complex injectable market is gaining traction in the injectable therapies, however manufacturing of it is critical. In this webinar, lets brainstorm on the downstream criticalities of these molecules and how to handle the same.
The principal objective of dosage form design is to
achieve a predictable therapeutic response to a drug
included in a formulation which is capable of large scale
manufacture with reproducible product quality. To ensure
product quality, numerous features are required, like
chemical and physical stability, suitable preservation
against microbial contamination if appropriate,
uniformity of dose of drug, acceptability to users
including prescriber and patient, as well as suitable
packing, labeling, and validation1
.
Process validation establishes the flexibility and
constraints in the manufacturing process controls in the
attainment of desirable attributes in the drug product
while preventing undesirable properties. This is an
important concept, since it serves to support the
underlying definition of validation, which is a systematic
approach to identifying, measuring, evaluating,
documenting, and re-evaluating a series of critical steps in
the manufacturing process that require control to ensure
a reproducible final product.3
USFDA defined process validation as “establishing
documented evidence which provides high degree of
assurance that a specific process will consistently produce
a product meeting its pre determined specifications and
quality characteristics.”5
Solid dosage forms include tablets and capsules. The
manufacturing of solid dosage forms involves extensive
powder handling. The powder must be blended for
uniformity and converted into the dosage form either
through compression or encapsulation. Typical
requirements include weighing, blending,
mixing/granulation areas, compression/encapsulation
areas, and coating areas. 2
Despite the ongoing development of more sophisticated
solid drug delivery systems, tablets are still by far the
most prevalent solid dosage form. The emphasis will be
on the practical inspectional requirement, rather than on
a theoretical approach that does not reflect the
practicalities (and problems) encountered when
validating actual production operations.
A tablet is a pharmaceutical dosage form. It comprises a
mixture of active substances and excipients, usually in
powder form, pressed or compacted into a solid. The
excipients can include binders, glidants (flow aids) and
lubricants to ensure efficient tabletting; disintegrants to
promote tablet break-up in the digestive tract;
sweeteners or flavors to enhance taste; and pigments to
make the tablets visually attractive. A polymer coating is
often applied to make the tablet smoother and easier to
swallow, to control the release rate of the active
ingredient, to make it more resistant to the environment
(extending its shelf life), or to enhance the tablet's
appearance
Addressing Raw Material Handling Challenges by Dry GranulationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2NXmi8O
Caking and clumping of pharmaceutical raw materials have a negative impact on manufacturing efficiency. Learn which benefits dry granulation provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
Buffers, salts and stabilizing chemicals are used in multi-ton quantities during pharmaceutical manufacturing. The handling of such quantities can be challenging: caking and clumping of chemicals, dust formation and laborious weighing have a negative impact on manufacturing efficiency and may even lead to process interruptions, quality deviations and operator safety risks. In many cases, these limitations can be overcome by granulated material.
Learn which benefits dry granulation by roller compaction provides and how granulated raw materials facilitate processability, speed up manufacturing processes and increase operator safety.
In this webinar, you will learn:
• Which effects clumping and caking of pharmaceutical raw materials can have on operations
• How dry granulation of raw materials can help overcome these issues
• Which technical and chemical parameters are key for a suitable granulation outcome
Webinar: How to Develop a Regulatory-compliant Continued Process Verificatio...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/CPVWebinar
Product life cycle consists of 3 phases: Process Design, Process Performance Qualification and the last and the lengthiest Continued Process Verification (CPV). As more and more biomanufacturing processes enter commercial phases, the critical need to understand how to efficiently perform CPV programs arises.
Explore our webinar library: www.emdmillipore.com/webinars
Key Considerations & Case Study for Building a cGMP Biomanufacturing FacilityMilliporeSigma
Every biopharma executive must make important decisions early in clinical development. One of these decisions includes defining the commercial manufacturing strategy for their biopharmaceutical and whether it makes business sense to build their own cGMP biomanufacturing facility. We have gained significant expertise throughout the design, build and ongoing operations of the Biodevelopment Center in Martillac, France that could prove invaluable to companies that are considering whether to build their own cGMP facility or outsource to a contract manufacturing organization. In this webinar, our experts share some key considerations for designing, building and operating an agile and flexible cGMP biomanufacturing facility successfully, safely, and profitably.
In this webinar, you will learn:
- How to design and build a flexible and agile facility
- The regulatory requirements for the facility
- How we have converted a stainless steel cGMP bioproduction facility in Martillac, France into a state-of-the-art, fully single-use cGMP facility
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Idei de organizare a camerei de zi
Camera de zi sau sufrageria este spatiul pe care-l utilizam cel mai mult dintr-o casa, mai ales daca pastram aici si televizorul sau calculatorul. Este locul de intalnire intre gazda si oaspeti si in acelasi timp, spatiul de joaca pentru copii.
ULTRACON-SERVICE LLC pressents
the EDDYCON C eddy current flaw detector. It is used for detection of surface cracks in various parts, cracks in holes and multilayered structures, surface and subsurface corrosion.
Eddy current is an acceptable method for detecting conductivity of non-ferrous materials and coating thickness.
For further information, please visit our website at www.ultracon-service.com.ua
The challenge:
Can you improve the yield and impurity levels while streamlining the production process?
How we said yes:
Baseline Experimentation revealed impurity and yield problems and an R&D program was launched to address the issues.
2. Acceleration Laboratory Services is an FDA
Quality is Paramount. Service is Superior.
inspected contract drug development and
research organization (CRO) headquartered in the
Kansas City metropolitan area. Our accomplished
associates bring advanced knowledge and
attention to detail — along with solid science and
an analytical perspective — to achieve quality
Quality Services
outcomes at any point during the drug development
process. Acceleration provides comprehensive, current • Drug Products (most dosage forms) • Antimicrobial Effectiveness USP <51> Acceleration Gives…
and customized data and information related to • Battery of Standard Tests • Sterility USP <71> Acceleration helps accelerate your drug
Acceleration serves clients of all sizes in the product development, analytical methods, • Compendial testing (USP, EP, & JP) • Pharmaceutical Water Testing development through:
pharmaceutical, animal health, other life sciences testing and marketing of pharmaceuticals, • Excipients (Vendor Qualification Support)
and food/beverage industries. Acceleration as well as other types of products. We provide • Certificate of Analysis Generation Manufacturing Services Highest Quality
GMP Manufacturing Phase I & II Clinical Supplies • FDA Inspected
offers analytical services at every phase of the contract testing for a variety of life science Stability Testing
• Powder in Capsule • GMP/GLP
development continuum, including evaluation of businesses, large and small, including virtual • Drug Substances
• Powder in Vial • Intensive Laboratory Training
chemistry, safety, and stability through packaging, companies. • Drug Products
• Aliquotting/Subdividing • Intensive SOP Training
labeling, storage and shipment of product. Our • ICH (5°C, 25°C/60% RH, 30°C/65% RH, • Independently Audited
We also provide specialized solutions to
40°C/75% RH) Clinical Packaging/Labeling
end goal is to make sure the product reaching the address your custom needs. Expedience
• ICH Photostability (Options 1 & 2) • Primary - Capsules/Tablets in Bottles
consumer is well characterized and as accurately • Custom Conditions (-20°C, 50°C/75% RH, • We will work with customers to meet
Acceleration focuses on: • Secondary – Packaging, Labeling
evaluated as possible. or per customer needs) • Distribution deadlines
• Analytical Chemistry Services • Special Rush Service
Associates with Experience and Acumen • Temperature Cycling Studies
• Manufacturing Services • Fully Validated Chambers - Monitored 24/7 Storage and Distribution
Clients enjoy a higher level of service with GMP Warehouse – Storage, Inventory, Aliquotting Creative Pricing
• Packaging and Labeling Services • Uninterrupted Power
• Discounts available for volume work
Acceleration associates averaging over 10 • Protocols & Global Distribution
• Storage and Distribution Services • Drug Substances • Discounts available for guaranteed work
years experience in the industry. All Acceleration • Submission Ready Reports
• Drug Products (in primary package and kits) • FTE contracts available
associates are degreed professionals. With an • Customized Solutions Additional Capabilities
• Excipients
associate turnover rate far lower than most contract • Controlled Substances
research organizations, customers enjoy stability Analytical Chemistry (DEA Schedules I – V)
• Analytical Method Development/ • Potent Compound Handling
and consistency, which directly affects quality.
Validation/Transfer • GMP Routine Sample Testing
At Acceleration Laboratory Services, our first and • Assay, Related Impurities, Chiral • Reference Standard Subdivision
and Distribution
foremost principle is “people first.” We are founded • Forced Degradation Studies
• Compatibility Studies
on that principle and we remain dedicated to the • Residual Solvents
• Cleaning Validation
ideal that people matter most. Our associates are • HPLC, UPLC, GC, Dissolution, LC/MS, IR, KF,
• GLP Dosing Solution Preparation
etc.
both technically astute and customer oriented; they • GLP Dosing Solution Analysis
• Reference Standard Qualification • GLP Stability Studies
understand that quality is not measured just in the
• Method Remediation or Optimization • CMC Support
accuracy of results. A true quality product must be • Development/Validation Report • CMC Consulting
timely, accurate, and meet or exceed our customer’s (appropriate for “Drop-In” to Regulatory • Package Integrity
expectations. Filing)
Our objective is to make each proposal – every Microbiology Testing
project – a successful venture for both our customers Release Testing • Bacterial Endotoxin USP <85>
• Drug Substances • Bioburden/Microbial Limits USP
and ourselves.
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