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Pulmonary Product Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Ascent has expertise, state of art infrastructure and diverse experience to provide pharmaceutical formulation development solutions for various dosage forms like pulmonary products.

Dry Powders for Nasal Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Dry Powder Formulation Technologies For Inhaled Biologics

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

ParticleMax™ is a spray drying particle engineering technology was developed to deliver dry powder biologics and can produce uniform mixtures of drugs and excipients and can be used to co-formulate multiple APIs in the same particle at a fixed ratio.

Solutions for Nasal Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Suspensions for Nasal Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Dry Powders for Oral Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Solutions for Oral Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Suspensions for Oral Inhalation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Quotient Sciences has almost 30 years of experience developing a breadth of formulations across a range of indications.

Inhalation Formulation Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

For global pharmaceutical companies with inhaled drug pipelines, Catalent is your service solutions partner that enables you to enhance the value of your treatment and improve your product’s speed to market.

Nasal Spray Development

API & Drug Product Development >> Formulation Development >> Inhalation / Nasal

Preformulation/reformulation for solid, semi solid (only orals) and topical formulations dosage form, pre-clinical formulation, prototype development (lab scale) batches and tech transfer support.

Inhalation / Nasal Formulation Development, Inhalation nasal formulations are developed for local and quick action that deliver the drugs through nasal route formulations such as decongestants and allergy treatments, as well as for the rapid delivery of systemic therapies, hormones and migraine treatments. In each case, the effectiveness of drug delivery depends on both the delivered dose and the size of the droplets produced by the spray pump during actuation. The latter influences both deposition and, potentially, bioavailability. In turn, droplet size derives from the characteristics of both the device and formulation, in combination, as recognised in the testing protocols. Inhalation drug product development can be an effective way of achieving therapeutic concentrations locally in the lungs or nasal passages while limiting systemic exposure. However developing such drug products for inhalation requires specialised formulation and characterisation expertise in order to ensure effective and quality nasal product development. Nasal Products devlopment As with all in vivo nasal products developments, nasally administered drugs require a consistent and reproducible dose. Unlike a tablet, the dosing for Pulmonary Product Development of a nasal spray must be achieved using a mechanical device. In addition, the device may deliver up to 200 doses compared with a single dose contained in a tablet. Therefore, good nasal product CDMO development for enhancing the consistency of dose delivery to nasal sites of action requires the formulation characteristics and delivery device capabilities to be harmonized. Formulation researchers have recently explored new methods of delivering macromolecules nasally by using delivery systems such as liposomes, microspheres and gels, as well as applying bioadhesive additives such as chitosan and other ingredients to improve absorption via prolonged retention on the nasal mucosa. Other ingredients have also been used to increase the viscosity of formulations, with the goal of improving product stability during storage and increasing residence time of the formulation within the nasal passages following delivery. Developing nasal drug delivery systems by CDMOs offers an effective range to possibilities to provide the therapeutic area faster. Various CDMOs inhalational products services are Dry Powders for Nasal Inhalation Development, Solutions for Nasal Inhalation Development (CDMO), Suspensions for Nasal Inhalation Development, Dry Powders for Oral Inhalation Development, Solutions for Oral Inhalation Development, Nasal Spray Development and Nasal decongestants Development. For the developer, the broad range of options that may be included as ingredients in a nasal spray development CDMO presents many challenges; for instance, the addition of excipients can aid drug retention or absorption following delivery, but may also have a significant effect on the properties of the spray plume, affecting the deposition site of the aerosol development CDMO. Guo demonstrated that for a aerosol Development CDMO nasal cast that nasal sprays with a low viscosity provided greater surface coverage than higher viscosity formulations, with this being related to the particle size and, possibly, the plume geometry. Other studies have also confirmed that during nasal Sprays Development CDMO importance of the geometry of the nasal passages and the properties of the spray plume in influencing spray deposition. Guo concluded that "spray pattern, plume geometry and droplet size distribution all appeared to provide critical data for the assessment of nasal pump performance, as it related to reproducible delivery from the device during inhalation sprays development CDMO . Therefore, droplet size measurements, along with plume pattern and geometry assessments provide an in vitro test that can be used to understand the performance of the delivery device and how this is affected by changes to the formulation. These methods (with the exception of plume geometry) are also used as quality control tests. Various nasal inhalers CDMO examines the in vitro performance of different polymers, which may be used to improve stability or prolong retention, in model nasal spray formulations. Viscosity and droplet size were used to assess performance from a commercially available nasal spray device. Nasal Sprays development Nasal spray drug products contain therapeutically active ingredients (drug substances) dissolved or suspended in solutions or mixtures of excipients during the nasal sprays development CDMOs (e.g., preservatives, viscosity modifiers, emulsifiers, buffering agents) in nonpressurized dispensers that deliver a spray containing a metered dose inhalers development CDMOs of the active ingredient. The dose can be metered by the spray pump or could have been premetered during manufacture. A nasal spray development unit can be designed for unit dosing or can discharge up to several hundred metered sprays of formulation development CDMO containing the drug substance. Nasal sprays CDMOs are applied to the nasal cavity for local and/or systemic effects. Although similar in many features to other drug products, some aspects of nasal sprays drug products CDMO may be unique (e.g., formulation, container closure system, manufacturing, stability, controls of critical steps, intermediates, and drug product). These aspects should be considered carefully during the nasal formulation development program because changes can affect the ability of the product to deliver reproducible doses to patients throughout the product=s shelf life. Inhalation Solutions and Suspensions Development Inhalation solution and suspension drug products CDMOs are typically aqueous-based formulations that contain therapeutically active ingredients and can also contain additional excipients. Aqueous-based oral inhalation solutions and suspension must be sterile (21 CFR 200.51). Inhalation solutions development CDMO and inhalation suspension CDMO are intended for delivery to the lungs by oral inhalation for local and/or systemic effects and are to be used with a specified nebulizer. Nasal suspension development are for unit-dose presentation is recommended for these nasal solution drug products development to prevent microbial contamination during use. The container closure system used during Inhalation Products development CDMO of for these drug products consists of the container and closure, and can include protective packaging such as foil overwrap. Inhalation sprays development CDMO used for the formulation and the container closure system. The formulations are typically aqueous based and, by definition, do not contain any propellant. Aqueous-based oral inhalation sprays development CDMO must be sterile (21 CFR 200.51). Inhalation sprays development CDMO are intended for delivery to the lungs by oral inhalation for local and/or systemic effects. The products contain therapeutically active ingredients and can also contain additional excipients. The formulation can be in unit-dose or multidose presentations. Testing parameters During the inhalation formulation development CDMO testing parameters are recommended for inhalation solution, suspension, and spray drug products development. Appropriate acceptance criteria and validated test procedures should be established for each test parameter. In general, the acceptance criteria should be reflective of the data obtained from the submitted batches (e.g., critical clinical, biobatch, primary stability, production). Certain nasal formulation development CDMO tests performed during th(e.g., pH, osmolality, viscosity, net content) can substitute for the release testing if justified. However, the acceptance criteria should remain a part of the drug product specification. The regulatory perspective Regulatory guidance recommends that nasal sprays are tested as combined products (device and formulation together) to determine reproducible delivery. Achieving clinical efficacy and good product consistency relies on understanding and controlling the interactions between device and formulation, which together dictate performance.Invitro testing is specified for a range of variables, with droplet size being one of the most important parameters. Inhalation Formulation Development CDMO Droplet size measurements are used to assess: Quality — the consistency of performance; for example, over the lifetime of the product, from batch-to-batch, or after storage. Safety — droplets of 10 µm and below may pass through the nasal passages and penetrate into the lungs. Consequently, APIs in this fraction will enter the body by pulmonary absorption, rather than by the intended route. Inhalation Formulation Development CDMO for Quantifying the extent of this risk and assessing the associated clinical effect is essential. Efficacy — droplet size influences the site of deposition within the nasal passages, which may affect bioavailability. The FDA recommends droplet size measurement at several stages of the product life cycle, including: development/optimisation and preclinical/IND trials; stability, robustness and in vitro bioequivalence testing; and batch release. Inhalation Formulation Development CDMO. The European Medicines Evaluation Agency (EMA) sets out similar guidance for droplet sizing as part of product applications, although the extension to in vitro bioequivalence testing is not as clearly stated. Such testing allows developers to successfully optimise controllable parameters to meet performance targets and provides quality control for the manufactured product. The two droplet sizing techniques for nasal spray testing and nasal Suspensions CDMO highlighted by the regulators are cascade impaction and laser diffraction. , Cascade impaction is a relatively time and labour-intensive technique that allows measurement of the amount of API in the sub -µm aerodynamic fraction, which is important for Nasal Suspensions CDMO assessing the potential for pulmonary absorption (as noted above). Laser diffraction, in contrast, is sufficiently rapid to provide real-time size measurement of the whole droplet rather than just the API. Because of this, laser diffraction is an excellent tool to use during the development cycle when the aim is to target a defined droplet size and obtain an early assessment of the percentage of droplets less than 10 µm in size. The DSD of a nasal spray for Inhalation And Nasal Product Development is a critical parameter, since it significantly influences the in vivo deposition of the drug in the nasal cavity. The droplet size is hereby mainly influenced by the design and handling, e.g., the actuation parameters, Dry Powder Formulation Technologies For Inhaled Biologics development of the device, as well as by the formulation, and the prevalent median droplet size is between 30 and 120 ?m. If the droplets are too large (>120 ?m), deposition takes place mainly in the anterior parts of the nose, and if the droplets are too small. Considering the potential benefits from nasal route for development of metered dose inhalers of administration, we should expect to see a range of novel nasal products reaching the market in the near future. They will include not only drugs for local treatment but also for systemic protection against infections. The development of drugs for directly target the brain in order to attain a good therapeutic effect in CNS with reduced systemic side effects. Nasal Inhalers CDMO for Nasal drug delivery can be affected by several factors e.g. Nasal Inhalers CDMO Biological Factors, Physiological factors, Physicochemical Properties of Drugs, Physicochemical Properties of Formulation. DPI formulations nasal spray drug products development contain active ingredients dissolved or suspended in solutions or mixtures of excipients in nonpressurized dispensers that deliver a spray containing a metered dose of the active ingredient. Critical characterization test for nasal spray includes spray pattern, droplet size distribution, Spray Content Uniformity these depend on formulation as well as device properties. Nasal spray drug products development CDMO contain therapeutically active ingredients (drug substances) dissolved or suspended in solutions or mixtures of excipients (e.g., preservatives, viscosity modifiers, emulsifiers, buffering agents) in nonpressurized dispensers that deliver a spray containing a metered dose of the active ingredient. Development of metered dose inhalers CDMO. The dose can be metered by the spray pump. A nasal spray unit can be designed for unit dosing or can discharge up to several hundred metered sprays of formulation containing the drug substance. Development of metered dose inhalers. Nasal sprays drug development CDMO are applied to the nasal cavity for local and/or systemic effects. Although similar in many features to other drug products, some aspects of nasal sprays may be unique (e.g., formulation, container closure system, manufacturing, stability, and drug product). Metered dose inhalers development CDMO, Metering and spray producing (e.g., orifice, nozzle, jet) pump mechanisms and components are used for reproducible delivery of drug formulation, and these can be constructed of many parts of different design that are precisely controlled in terms of dimensions and composition. Energy is required for dispersion of the formulation as a spray. Dry powder for inhalation CDMO,This is typically accomplished by forcing the formulation through the nasal actuator and its orifice. The formulation and the container closure system (container, closure, pump, and any protective packaging) collectively constitute the drug product. The design of the container for inhalation products development CDMO closure system affects the dosing performance of the drug product. Both solution and suspension formulations can be formulated into nasal sprays. Metered spray pumps development CDMOs have, since they were introduced some four decades ago, dominated the nasal drug delivery market. The pumps typically deliver 100 ?l (25– 200 ?l) per spray, and they offer high reproducibility of the emitted dose and plume geometry in in vitro tests. The particle size and plume geometry can vary within certain limits and depend on the properties of the pump, the formulation, the orifice of the actuator, and the force applied. Inhalation drug products CDMO, Traditional spray pumps replace the emitted liquid with air, and preservatives are therefore required to prevent contamination. Inhalation drug products developments CDMO, However, driven by the studies suggesting possible negative effects of preservatives, pump manufacturers have developed different spray systems that avoid the need for preservatives. More recently, pumps have been designed with side-actuation and introduced for delivery of fluticasone furoate for the indication of seasonal and perennial allergic rhinitis. The pump was designed fo nasal drug products development CDMO with a shorter tip to avoid contact with the sensitive mucosal surfaces. New designs to reduce the need for priming and re-priming, and pumps incorporating pressure point features to improve the dose reproducibility and dose counters and lock-out mechanisms for enhanced dose control and safety are available.

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