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Emperor Boulevard, 4815, Durham, NC, 27703, US
The purpose of this study was to evaluate the development of oral fast disintegrating tablets by conventional direct compression method and statistical design of experiment. Better results were obtained with lower strength than higher strength tablets.
Released By Thermo Fisher Scientific
The purpose of this study was to evaluate the incidence of cracking of gelatin capsules filled with commercially viable examples of hygroscopic placebo formulations and low viscosity hydrophobic liquids.
The purpose of this study was to understand the roller compaction behavior of different model placebo formulations using smooth rolls and to compare their performance against different roll surfaces. This study clearly demonstrates the differences in throughput.
The purpose of this study was to investigate the root cause and potential mechanism behind the areas of discoloration on stability samples of pharmaceutical tablets. The most likely mechanism of tablet discoloration was related to a dehydration reaction.
The purpose of this study is to further optimize and assess the effect of refining magnesium stearate lubricant, sweetener, hardness and thickness levels on the design of a fast disintegrating formulation by direct compression.
The purpose of this study was to establish the design space and operational conditions for the roller compaction process of a placebo formulation that closely represents a low-dose active formulation. The ribbon density, tensile strength, mean granule size and granule surface area can impact the process.
The purpose of this study was to develop and optimize a Wurster fluid-bed coating process for applying an enteric coating onto empty hypromellose capsule caps and bodies to achieve acid resistance after filling. Coated capsules were manually filled and closed without damage to the coating.
The purpose of this work was to study the use of LIBS (Laser Induced Breakdown Spectroscopy) as an in-process monitor for uniformity during an API tablet coating process. In-process measurements were taken up to the coating endpoint, and evaluated to obtain tablet coating thickness and uniformity information.
The purpose of this study was to evaluate the use of a true placebo DoE to create a platform process in which to define a viable active formulation process on a roller compactor. The use of placebo DoE was effective in creating a platform process for active feasibility trials and scale-up using minimal API.
The purpose of this study was to investigate the effect of wet granulation factors on the compression behaviour and other physical characteristics of a slow release polymeric matrix formulation. The water quantity used for granulation was the most important contributing factor.
The purpose of this study was to compare the reliability and reproducibility of manual and automated dissolution-UV methods. Extended-release acetaminophen was selected as the model. This study demonstrated that the fiber optic probe system was preferred over the on-line UV system.
The purpose of this study was to evaluate the HPMC banding process and morphology using different banding agents, and compare HPMC banding and regular gelatin banding processes and to look for a possible new water based HPMC banding process and banding agent.
The objective of this study was to evaluate a novel technique for compressing blends at low temperatures using Vortex Coolers. Processing of low melting APIs or excipients such as solubilizers/bioavailability enhancers into a tablet dosage form has been a challenge.
The objective of this study was to achieve the drug release rate which is independent of time and the concentration from a solid oral tablet dosage form. A zero order, pH independent release formulation for a freely water soluble model drug (Buspirone HCL) was developed.
This sell sheet highlights Patheon’s Puerto Rico Operations which specializes in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.
When future commercial volumes are anticipated to be relatively low, small scale filling lines offer a significant advantage. This sell sheet discusses how small quantities of lifesaving niche and orphan drug products can be most effectively manufactured on small scale equipment.
Patheon’s Whitby facility has utilized roller compaction for pharmaceutical manufacturing for over 20 years. This sell sheet discusses the key benefits of this granulation process.
This sell sheet gives an overview of Patheon’s Quick To Market™ program, which offers accelerated transfer of commercially available products from an existing manufacturing plant to a plant within Patheon’s network.
This sell sheet gives an overview of Patheon’s 4•6•8 Promise™, which ensures that projects will be completed in the fastest possible timeframe, without compromising high standards.
This sell sheet discusses a tech transfer success story at the Bourgoin facility. 33 tech transfers were completed on time and within budget, thanks to the regulatory experience, technical expertise and flexible management capabilities of the Patheon European network.
Patheon is 100 percent focused on being the best service provider to our clients. This sell sheet details several honors awarded to Patheon in categories such as “preferred supplier” and “best tech transfer.”
The purpose of this study was to evaluate the effect of increasing aspirin content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations.
The purpose of this study was to investigate the over lubrication susceptibility of model folic acid formulations inside a tablet press force feeder and the effects on the physical properties and dissolution performance of the tablets. The results obtained from the study showed that the residence time of a powder
The objective of this study wast o evaluate the HPMC banding process and morphology using different banding agents, and compare HPMC banding and regular gelatin banding processes. To look for a possible new water based HPMC banding process and banding agent to replace the current alcohol/water based HPMC banding.
The objective of this study was to determine critical process parameters which influence the characteristics of spray dried materials for quick small scale formulation screening using DOE. Different polymers (PVP-K30 in dichloromethane and HPMCAS LF in 2:1 w/w of dichloromethane: methanol) were spray dried at a b
The purpose of this study was to evaluate the effect of lactose monohydrate of the tabletability performance of roller compacted blends a s a preliminary screening study towards development of a model for roller compaction formulations. The flowability based on Carr’s Index measurement decreased slightly.
The purpose of this study was to define the design space for blend lubrication by quick and quantitative tooling adhesion predictions using miniaturized tooling tests. The results may define and predict the design space for processing incoming lots of drugs and excipients.
The purpose of this study was to investigate the source of two unknown impurities (RRT 0.45 and RRT 0.76) detected in a low-strength solid oral dosage form (tablets) packaged in cartridges in a foil pouch under accelerated and long-term storage conditions.
The purpose of this study was to emphasize the use of dynamic vapour sorption as a tool in understanding the behaviour of crystalline APIs in the presence of moisture, and which experimental set up conditions best help to understand the movement of water/moisture.
The purpose of this study was to understand the influence of capsule design, manufacturing scale, storage condition (humidity) and hygroscopicity on cracking of liquid filled hard gelatin capsules (LFHC). This study confirms that liquid filled hard gelatin capsule cracking is associated with capsule design.
The purpose of this study was to develop and validate an analytical method for the determination of residual detergent, Benzalkonium Chloride, in samples collected after cleaning of pharmaceutical manufacturing equipment with industrial detergents.
The objective of this study was to demonstrate process optimization using dependent variables that correspond to key process phenomena to define the design space. This approach is an experimentally efficient technique for process development, scale-up, and troubleshooting.
Patheon is fully committed to the development, optimization, and scale-up of prefilled syringes and cartridges. Our experience spans a large number of projects for a wide variety of large and small molecules.
The purpose of this study was to evaluate the effect of increasing naproxen content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations. Compactibility is the dominant factor in determining tabletability in the cas
The purpose of this study was to evaluate the effect of increasing ibuprofen content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations.
The purpose of this study was to develop large diameter, non-disintegrating controlled-release tablet formulations using hydrophilic polymer matrix systems for pH sensitive low solubility drugs. The results indicated that interactions of drug, excipients and polymer play an important role.
The purpose of this study was to assess the effect of externally applied magnesium stearate lubricant on the compression of unlubricated refractory blends with mini-tooling on a development scale rotary tablet press.
The purpose of this study was to evaluate the use of the hot melt granulation technique for improving dissolution and bioavailability of a poorly soluble API. Coating was achieved by adjusting the spray rate and inlet temperatures. The final formulation was found to be stable.
The purpose of this study was to investigate approaches to determine the near UV radiation exposure in an ICH Q1B Option 2 photostability chamber by quinine actinometry. Different approaches were evaluated and showed considerable variances. All factors must be approached scientifically and standardized for photos
The objective of this study was to enhance the solubility and in-vitro dissolution/bioavailability of a low soluble (0.5 mg/mL) BCS Class II compound (API). A mixture approach enabled selection of excipients and to arrive at an optimal ratio based on the excipient properties.
The goal of this study was to design a platform technology for a controlled release orally disintegrating tablet (ODT) using cationic ion exchange resins which will facilitate taste masking. Sodium polystyrene sulfonate, USP (AMBERLITETM IRP69) was used as an ion exchange polymer.
The purpose of this study was to determine critical process parameters which influence the characteristics of spray dried materials for quick small scale formulation screening using DOE. Cconcentration of the spray dry solution can significantly affect the properties.
With an expert team and fully integrated specialized scientific resources already in place, Patheon was able to take this high-potency small-molecule drug candidate from preclinical development all the way to commercial launch in less than five years.
This brochure gives an overview of Patheon’s solid and sterile dose forms, including a picture and detailed description of each. Capabilities are also detailed by site.
This brochure provides an overview of Patheon as a leader in pharmaceutical development and commercial manufacturing of a broad range of sterile and solid dose forms including clinical supply materials.
With the experience of nearly 400 highly potent compounds, you can count on Patheon for the development and manufacturing of these complex pharmaceuticals, including hormones and compounds with OELs in the nano gram per cubic range.
Patients didn’t like the extremely bitter flavor of a customer’s tablet. Patheon created and tested a custom taste masking solution to improve patient compliance, and open the door to exclusivity in the pediatric market.
Patheon transferred 33 solid dose products, 8 formulations, 11 packaging formats and 85 regulatory variations from an outdated facility in less than three years, and without interruption of supply.
A company was limited by packaging capacity at their own facility. Patheon adapted a packaging line to meet the specific demands of their project, saving the customer the capital expense of upgrading their own facility.
A new customer had received an emergency use authorization from the U.S. FDA. The demand was large, and speed to production was critical. Patheon provided the readily available capacity and expertise to help the company promptly answer the call.
A pharmaceutical company came to Patheon with a suspension formulation that’s high viscosity curtailed production speeds. We reengineered our manufacturing equipment to work efficiently with this specific product to increased throughput by four fold.
Patheon’s expertise in lyophilization is clear to see in our scale up three different products from our PDS lab unit to our GMP 7m² system. Batch-to-batch, consistency of all key analytical properties was excellent for all three products.
Patheon’s exceptionally efficient approach to technology transfers ensured an uninterrupted global supply for a company having critical quality compliance issues with another CMO.
This sell sheet gives an overview of Patheon’s Quick to Clinic™ Program, which offers High-Quality Phase I Clinical Trial Materials in as Little as 12 Weeks. What’s more, this accelerated program gives you access to six flexible dosage forms and includes clinical trial stability studies.
Patheon conducted a study to challenge the claim that a PDA detector has the capability of detecting co-eluting components in HPLC peaks since this is based on UV spectroscopy, which is relatively nonspecific.
A medium-size company needed to develop and validate a method for quantification of several potential genotoxic impurities in their drug substance. Their procedure, which included a derivatization step prior to analysis, suffered from variable recovery.
A large pharmaceutical company wanted to develop a bilayer tablet, each layer having different release profiles. One of the layers was low dose and moisture sensitive. There were also layer lamination issues during formulation development and in storage.
Our work for a customer needing clinical trial materials revealed that their transferred validation of HPLC methods was insufficient and poorly reproducible. Patheon resolved the issue averting potential delays to the project’s overall timeline.
Patheon had developed a globally marketed coated tablet product for a medium-sized pharmaceutical company. To help them capitalize opportunities in the pediatric market, we developed a fast dispersible tablet line extension.
Patheon transferred a customer’s manufacturing process and delivered an improved formulation with better stability, scalability and manufacturability. We also prepared documentation for a robust CMC package for their NDA submission.
The chemical structure of a customer’s new molecule indicated potential for oxidative degradation and hydrolysis. Through binary excipient compatibility testing, Patheon was able to focus efforts on a formulation with maximum stability.
A new degradation product was observed in accelerated stability chromatograms for a new formulation. A tentative structural assignment was made by the customer’s consultant but needed to be verified.
A small biotech company was developing a compound with poor solubility and bioavailability. Patheon’s SoluPath™ parallel screening service quickly and cost-effectively determined the best formulation to overcome these issues.
EcoCaps™ – The non-animal alternative to gelatin has arrived.
Patheon’s Monza and Ferentino facilities are sterile manufacturing centers of excellence. This brochure highlights the extensive range of component formats that are available, allowing for the flexibility of additional formats to meet your needs.
Patheon offers fully integrated lyophilized product development services and commercial manufacturing for a wide range of molecule types. This sell sheet gives an overview of these specialized capabilities.
With a fully integrated network of U.S. FDA-approved sites across Europe, Patheon can satisfy sterile product needs from 1 to 10,000 units. This sell sheet highlights the breadth of capabilities from clinical development to process scale-up and commercial manufacturing and supply.
Chewels® – Innovative dosage form offers convenience and portability in an attractive and pleasant tasting chewable gel.
EnteriCare® – Delayed release delivery of your compound with the clear dosage form consumers prefer.
Solvatrol™- An effective method for enhancing solubility of active pharmaceutical compounds.
Versatrol™- Control and customize the release rate of your active Ingredients.
LiquiSoft™ – Convenient, pleasant tasting and appealing: Liquid-filled chewable gels.
Soflet® – A patented technology that enrobes tablets with either a gelatin or nonanimal film, resulting in a preferred dosage form that’s easy to swallow.
SoluPath™ employs parallel screening of multiple solubility and bioavailability enhancing technologies for a fixed price. That alone adds speed in the race to First In Man trials. But it’s the way Patheon delivers this service that maximizes speed, efficiency and value.
Patheon gives you the most royalty-free options when it comes to complex formulations. This brochure highlights our various technolgies and dose form capabilities including multi-release options, taste masking and lyophilization.
Patheon has developed over 80 large molecule dose forms. This sell sheet highlights Patheon’s extensive experience and capabilities ranging from early formulation development through to product commercialization of both liquid and lyophilized products.
Patheon’s Pediatric Services are dedicated to developing palatable formulations, including oral liquids, chewable tablets, dispersible tablets, sachets, oral disintegrating tablets and softgels. This sell sheet discusses the interactions between API, flavors, and sweeteners.
The Patheon Certified Consultants program draws upon the knowledge and expertise of top independent pharmaceutical consultants to assist organizations transitioning from discovery to delivery. This brochure highlights how Patheon is committed to being your solutions provider at every stage of development.
A variety of approaches are often needed to improve the bioavailability of low solubility BCS class II and IV compounds. This sell sheet discusses how Patheon combines biopharmaceutics knowledge, preformulation data, and manufacturing technologies with statistical Design of Experiments.
SoluPath Flex™, the customizable, fixed-price solution to rapidly improve solubility that features a menu of services that includes the price, API volume demand and the length of time required to provide the service. This allows customers to select options in conjunction with Patheon scientific expertise that wil
From preclinical development to commercial supply, Patheon leads the industry in the development and manufacture of mammalian cell culture drug substances. We give biotech companies the ability to pursue opportunities around the globe with a fully integrated network of facilities.
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