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Glaucoma is a group of eye diseases characterized by elevated intraocular pressure (IOP) and is the second leading cause of blindness. Treatment options for glaucoma include medications, laser therapy, and surgery. New therapies for glaucoma are emerging, including topical prostaglandin analogues, the IOP-lowering agent omidenepag isopropyl, netarsudil, and latanoprostene bunod. Alternatives to topical eye drops, such as selective laser trabeculoplasty (SLT) and sustained drug delivery devices, can provide long-term reductions in IOP. Microinvasive glaucoma surgery (MIGS) procedures, such as iStent inject, Hydrus Microstent, and gonioscopy-assisted transluminal trabeculotomy, offer a less invasive surgical approach for reducing IOP. [Extracted from the article]

The article informs that lyophilization is a well-established technique within the bio/ pharmaceutical industry and is a necessity for certain drug products that include unstable ingredients, require longer shelf-lives, or are temperature-sensitive, and explores how primary benefit of lyophilization is improved product stability. It mentions that general principle of lyophilization has hardly changed, but significant advances have occurred in process and product attribute understanding.

The article offers information on the role of connected delivery solutions in providing value to industry and patients, through improved medication adherence and outcome optimization. It mentions the views of Bill Welch, chief technology officer, Phillips-Medisize on the critical aspect to connected drug delivery as improving patient adherence to get desired outcomes from prescribed medications.

The article focuses on the result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes. Topics inlcude the drugs has intended for injection into the eye for the treatment of macular degeneration has related to aging and diabetes, the growth seen in the syringes market to expanding ophthalmic market, and the views of Gregory Sacha, senior research scientist at Baxter BioPharma Solutions, on the same.

Glaucoma is a progressive disease that results in damage to the retinal nerve fiber layer and ultimately can cause a measurable loss of functional vision. Treatment basics Early and consistent treatment with IOP-lowering medications is standard of treatment for patients with glaucoma. [Extracted from the article]

The article discusses the strategic implications for drug and device development with digital innovation in clinical trials . Topics include the COVID-19 pandemic accelerated the transition toward digital solutions that would align with public health guidelines; and guidance delivered by regulatory agencies on conducting clinical trials during the COVID-19 pandemic.

The article inform highly potent compounds present challenges with respect to process development, formulation, and delivery. Topic include features at the interface of drug delivery and highly potent APIs (HPAPIs) are the ability to maintain operator safety through containment of the API during processing and to deliver a drug product in which the HPAPI is dispersed, even when doses are as low as micrograms," asserts David Lyon, a senior research fellow with Lonza.

The article offers information on operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms. Topics include the views of David Lyon, senior research fellow with Lonza, on the highly potent APIs (HPAPIs) are the ability to maintain operator safety through containment of the API processing and to deliver a drug product, and the highly potent compounds present numerous challenges with respect to process development, formulation, and delivery.

The article informs that manufacturing a drug–device combination product is a complex process that must take into consideration variables in manufacturing the drug delivery device, such as an inhaler or an auto injector, as well as interactions between the drug and the device. It mentions about clinical and commercial manufacturing facilities for drug–device combination products, and the company is expanding its Global Innovation and Development site in Struer, Denmark.

The article focuses on the designing and then manufacturing a drug–device combination product is a complex process that must take into consideration variables in manufacturing the drug delivery device. It mentions that Pharmaceutical Technology spoke with the company's experts Justin Westendorf, product development manager; and Chris Conger, director of Connected Health Device Technology, about the best practices in manufacturing drug–device combination products.

The article offers information on challenges of biologics in formulation and development when approaching drug delivery. Topics discussed include information on benefits in developing biologic formulations for alternative routes of administration; use of overarching technological solution for overcoming the limitations for the various delivery routes; and focus on inhalation delivery.

The article reports on the increased use of wearable devices to deliver biologics. Topics discussed include the delivery challenges associated with biologic drugs, the ways in which drug developers are making biologics delivery easier with the use of wearable devices and the factors that should be considered in developing a wearable drug product. Also discussed are the companies that have developed wearable devices for drug delivery, including West and Sonceboz.

The article focuses on an extractables and leachables (E&L) guidelines regarding the investigation of orally inhaled and nasal drug product (OINDP) formulations in its delivery device components. Topics discussed include impact of leachables on patient safety, usage of a drug formulation and mentions several examples for illustrating the importance of a realistic study design.

The article offers information on importance of innovation in manufacturing technologies to ensure the availability of cell therapies. Topics discussed include challenges to sourcing manufacturing solutions for viral vector production like high cost of good manufacturing practice grade reagents; challenges related to meet the clinical and commercial manufacturing needs for curative therapies; and importance of contract development and manufacturing organizations in viral vector production.

There are numerous challenges to sourcing effective large-scale manufacturing solutions for viral vector production. Based on conversations with customers over the past several years, Univercells has identified the major hurdles in large-scale virus manufacture, which include expensive manufacturing facilities, lack of expertise, limitations in the number of scalable manufacturing.

The article discusses that wearable and smart devices aim for user-friendly subcutaneous drug delivery and also focuses on the human factors engineering (HFE) studies. Topics include using platform technologies that can be easily customized for multiple therapies is important for manufacturing cost-efficiency, which is particularly important for drugs that target smaller patient populations and human factors (HF) studies should be used to ensure that the product can be used effectively. INSET: Human factors engineering.

The article focuses on improving lung function in chronic obstructive pulmonary disease (COPD) and offers information on STIOLTO RESPIMAT tiotropium bromide and olodaterol inhalation spray as a treatment option for management of COPD. Topics discussed include the role of pharmacologic management in COPD, limitations of use and safety information for STIOLTO RESPIMAT, and dosage and administration as well as preparing and using the STIOLTO RESPIMAT inhaler.

The article explores Catalent enables pharmaceutical, consumer health, and biologics partners, including cell and gene innovators, launch more than 150 new products a year, and deliver over 75 billion doses to treat patients all around the world. With more than 85 years' experience across prescription and consumer markets, Catalent has the deepest expertise, the broadest offerings.

The article discusses formulation and delivery challenges due to the high viscosity of highly concentrated monoclonal antibodies (mAbs). According to Nicholas Warne, senior director, Formulations, Pfizer, viscous solutions require high injection force for drug administration and may also require prolonged injection time. It also results in product loss as the highly viscous solutions stick to the contact surface of the primary packaging.

The article focuses on development of drug delivery device for biologic drugs. Topics discussed include views of Johann Stasny, director, Global Sales Development, on the challenges in biopharmaceutical delivery orally, drug administration by freeze drying for increasing drug stability and shelf life, views of Kate Hudson Farmer, market insight strategist, on challenges in drug administration such as need of training for parents for its use and successful development of drug delivery device.

In this article the author discusses challenges concerning successful drug delivery. Topics include problems faced by patients and drug delivery device designers due to highly viscous injectable macromolecule drugs, factors to be considered for spring-powered autoinjection of drugs, and Bernoulli equations for understanding working of large-volume injectors and needle-free devices. A graph depicting viscous formulation delivery by needle-free injector is also presented.

The article reports on the market growth of prefilled syringes and its advantages to manufacturers, healthcare professionals, and patients. It mentions that the increasing use of biologics drugs, greater global demand for vaccines, the rise in drug delivery in non-medical settings, and more efficient drug administration are factors that drive growth of prefilled syringes. The benefits of prefilled syringes are noted, including dose accuracy, convenience and compatibility with injection devices.

The article presents the international pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies. Topics include the post-marketing regulatory environment is highly regulated and inspection driven, the biotechs are likely to find the greatest challenges in managing their pharmacovigilance (PV) obligations, and the European requirements are starker than for pre-marketing.

The article offers information on the considerations for the inhalation dosage forms for drug delivery to the lungs. Topics discussed include the selection of drug delivery devices, the metered dose inhalers (MDIs), and the selection of salt for the dosage. Also mentioned is the approach in which a drug development program is started using the dosage form.

The article offers information on the challenges in developing generic pressurized metered dose inhaler (pMDI). It explains the importance of knowing the physical attributes and pharmaceutical performance of the reference marketed product and to learn the regulatory and quality requirements of the target market. The development of generic pMDIs design must be optimized in order to be safe, efficacious, robust, and reliable during patient use and over the product shelf life.

The article presents the text of a roundtable discussion on the role of particle engineering in the formulation of inhaled therapeutics. Points discussed include the factors that control drug delivery to the lungs, the key considerations when developing an inhalation drug product, and the importance of particle engineering in pulmonary drug delivery.

The article discusses that Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations. Topics discussed include outsourced services within the bio/pharma industry are growing robustly driven by a variety of factors; and the views of Behzad Mahdavi, vicepresident open innovation biologics, cell & gene therapy, Catalent, on it.

The article focuses on the importance of cascade impaction for the measurement of aerodynamic particle size for orally inhaled and nasal drug products (OINDPs) in the U.S. It states that the process is a time-consuming process as well as being complex and costly to automate in the pharmaceutical industry. It mentions that proper understanding of the technique highlighting its usage and manipulation results to a core skills for those working in the sector.

The article offers brief information on several products related to pharmaceutical industry including the benchtop Xcelolab powder dispenser from Capsugel, the AT22OOO Magnehelic differential pressure gage from Dwyer Instruments Inc. and the lyophilization system from DSM Pharmaceuticals Inc.

The article focuses on the approaches, primarily live bacterial vectors, intended to achieve DNA vaccine delivery. It offers a brief overview of the history of intramuscular injection of DNA and its medical applications. It also discusses intramuscular electroporation, transdermal microneedles, and pressure injectors. Moreover, it explores the use of live bacterial vectors (LBVs) in oral vaccine delivery.

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties. The authors explain how a new technique using standard dissolution test equipment in combination with US Pharmacopeia methods for the dissolution testing of solid dosage forms can be used to differentiate the solubility of orally inhaled products. [ABSTRACT FROM AUTHOR]

Various factors affect the peformance and stability of dry-powder inhalers. The author reviews key considerations for formulating powders for use in inhalers and for selecting and using dry-powder inhaler devices and filling equipment. Also addressed are challenges involved in scaling up from laboratory to commercial product development. [ABSTRACT FROM AUTHOR]

The article offers information on the requirements for effective nasal drug delivery. It states that the efficiency of drug delivery depends on two factors including the size of droplets produced during actuation and the delivered dose. It notes that in order to achieve data concerning real-time droplet size development, a laser diffraction-based particle size analysis is a useful tool.

The article profiles the pharmaceutical packaging companies that will take part in the 2016 Pharmapack exhibit. The companies include Aptar Pharma, known for their aerosol, injection, and spray delivery system, and B. Braun Melsungen AG, which provides products for drug admixture, infusion, or injection. Also included are Catalent Pharma Solutions, a developer of drug delivery systems, and Hapa AG, a printing technology provider.

The authors investigated the effects of formulation and processing parameters on floating matrix-controlled drug delivery systems consisting of poly(styrene divinyl benzene) copolymer low-density powder, matrix-forming polymers, drug, and diluents. The tablets were prepared by direct compression, using seven hydrophilic matrixing polymers. Tablets were physically characterized and evaluated for in vitro release characteristics for 8 h in 0.1 N HCl. The authors studied the effect of low-density copolymer addition and drug-release patter. While varying the concentration of low-density copolymer, the floating lag time of the formulation was checked. The authors showed the optimized formulation exhibited the floating behavior of the low-density drug delivery systems and accurate control and prolonged drug-release patterns. [ABSTRACT FROM AUTHOR]

In this article the author discusses the issue of moving an injectable therapeutic to prefilled-syringe format. He explores the benefits of the move which include meeting the demands of physicians and patients who look for easier administration, helping differentiate the product from competing drugs, and increasing sales of active pharmaceutical ingredient (API). He also explores the regulatory strategy in changing the presentation of the drug.

The article focuses on the use of several drug-delivery technologies for orally disintegrating tablets (ODTs) in the U.S. It views on the capacity of the technologies to present the desired ODT quality and performance attributes. It also explores the significance of the publication of "Guidance for Industry: Orally Disintegrating Tablets," by the U.S. Food and Drug Administration.

The article reports on the change of inhalers from CFC to HFA in the U.S. The U.S. Food and Drugs Administration (FDA) is advising the consumers to switch on the new inhaler before 2009. However, the new HFA inhalers cost significantly more and have no cheaper generic volumes which mean patients will have to spend much of their money. According to FDA, there is already an adequate supply of such inhalers, but pharmacists are complaining about the shortages of the product. In addition, the confusion over the change of inhalers will give pharmacists the opportunity to educate patients and to offer proper inhalation technique.

This article analyses the progress made in buccal drug delivery research during the last 5 years and introduces a new high-tech approach to achieve controlled delivery. [ABSTRACT FROM AUTHOR]

The article focuses on the issues concerning the status of inhaled insulin and other inhalable drugs in the U.S. According to the author, several pharmaceutical companies continue to develop these drugs despite the problems experienced by Pfizer Inc.'s Exubera. They believe that the respiratory delivery of insulin and other biologicals remains a practical and worthy goal.

The article focuses on the areas where improvements in delivery are most needed to create a top ten list of opportunities in the drug delivery systems industry. Among these areas include, oral delivery of proteins, oral controlled release and delivery across the blood brain barrier. Meanwhile, author concludes that a drug delivery technology must bring a real advantage to the patient such as improved efficacy and safety in order to be successful.

This article describes the latest developments in dry powder inhaler (DPI) systems, including the nature and production of active pharmaceutical ingredient particles, formulation considerations for powder blends, and recent developments in DPI devices. [ABSTRACT FROM AUTHOR]

The article focuses on the increasing popularity of prefilled syringes in the U.S. According to the author, the increasing demand for prefilled syringes is propelled by its multifaceted benefits for both the manufacturer and patient which includes ease of use, ease of manufacture, and less overfill. Moreover, to meet the growing demand for prefilled syringes pharmaceutical companies have devised processing innovations to enhance the quality of the product and meet the demands of the market.

The article informs that metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options. It mentions that infusion errors can lead to adverse incidents and, at worst, prove fatal. It also mentions that bio/pharma companies to seek out ways in which they can be more efficient during drug development.

The article provides an overview of microstructured transdermal systems (MTS) technology with the emphasis on solid-coated MTS for drug and vaccine delivery. MTS is particularly well suited to vaccine delivery because it provides a pain-free alternative to injection. In addition, various configurations of the MTS technology have been described.

Lactose, in particular alpha-lactose monohydrate, is typically used as ‘the’ carrier in dry powder inhalers. Even though these often tailored materials allow the delivery of medicines to the body in doses that are much lower than by ‘conventional’ solid dosage forms, the use of this excipient in this application is posing characterization and regulatory challenges to both suppliers and users. [ABSTRACT FROM AUTHOR]