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MedPharm Ltd

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Guildford, GB

About MedPharm Ltd

MedPharm is the world’s leading contract provider of topical and transdermal product design and development services.  We are a full service CDMO specializing in semi-solids providing development services from formulation development through GMP clinical manufacturing.  MedPharm, recognised for their scientific rigour by regulators and investors alike, are experts at reducing risk and accelerating development times through their unique cost-effective performance testing models.


Over the last 20 years, MedPharm has supported the development and approval of 55 marketed products around the world including the U.S., Europe, and Japan.

Our Services (18)


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Drug Development

Price on request

Otic Product Development


MedPharm has developed specific drops, lotions and other topicals for treating outer and middle ear conditions. This experience extends into the development of drops and foams, both of which are effective formulations for treating the ear canal.


We have developed bespoke performance models using otic tissue in the most relevant ex vivo model to support our clients’ product development.


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Topical Formulation

Price on request

MedPharm has more than 20 years experience developing topical and transdermal formulations.  We can begin as early as API screening and we support pre-formulation activities, lead formulation selection, formulation optimization and reverse engineering.  We have had a role in taking over 55 products to market.  We partner with large and small companies in the cosmetic, OTC, Rx and medical device industries to de-risk their early development activities to develop formulations that meet target product profiles.  

Respiratory Cosmetics Dermatology Inflammation Ophthalmology Rare Disease Pharmaceutical Women's Health and Prenatal Care Show 8 more tags Show less

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Inhalation Product Development

Price on request

MedPharm has decades of experience developing and characterizing suitable drug products and devices for delivery to the nasal cavity and lung. We have developed numerous respiratory products currently marketed in the US and Europe. Our successful creation of performance models for MDI, DPI and nebuliser formulations has been made possible by the extensive and specialized expertise of our scientists.


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Ophthalmic Drug Development

Price on request

Developing drugs for the eye is a significant challenge. The eye is a complex organ with unique anatomy and physiology, and it can be difficult to overcome its natural protective barriers. MedPharm has an outstanding track record of developing drops, lotions and injectables covering conjunctival, corneal, intravitreal and transscleral routes of delivery.

MedPharm has developed specific proprietary models for measuring trans-corneal penetration. These models make use of human or porcine cornea, and have helped optimise formulations and understand the fate of products applied without having to run in vivo trials.

The collective expertise of our scientists has led to the successful development of commercial topical, intravitreal (intra-ocular) and trans-scleral (peri-ocular) products for both immediate and controlled release.


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Transdermal/Transmucosal Drug Delivery Systems

Price on request

MedPharm develops bespoke performance models for clients using relevant tissue sources in these highly niche markets. By producing robust data to support our products clinical efficacy and extend marketing claims, we provide clients with the optimal development and regulatory strategy throughout the development process.

Our scientists have direct expertise in developing a wide range of formulations optimized for mucosal membrane treatment including creams, gels, ointments, suppositories, foams, sprays, lotions, lozenges and films.


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In Vitro Permeation Testing (IVPT)

Price on request

MedPharm offers its customers options for IVPT, including our unique MedFlux-HT® automated flow-through system or classic static cells.

IVPT is used to measure the permeation and penetration of a drug through tissue and is an essential tool for optimising topical and transdermal formulations. This is because a drug’s ability to permeate any tissue is very dependent on the quantity and quality of the excipients used. It cost-effectively provides a measure of performance of a product using human tissue and removes the uncertainty and ethics of working with ex vivo animal models.


IVPT is a cost-effective method used to demonstrate:

The optimisation and characterisation of formulation performance

De-risking clinical trial decisions

Product performance to potential investors

The bioequivalence of a generic compared to an originator product

New marketing claims to educate key opinion leaders


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Drug Release Studies/In Vitro Release Testing (IVRT)

Price on request

MedPharm leverages its 20 years of experience to help develop and validate IVRT methods for its clients. We successfully perform IVRT based on FDA and EMA guidelines and continue to influence how these methods are utilised in regulatory submissions.

IVRT is the established method recognised by regulators, and is commonly used for measuring the release of the active component(s) from semisolid products. Regulators are increasingly requiring validated IVRT methods as part of product release and stability specification.



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Ex Vivo Disease Models

Price on request

When trying to de-risk a clinical trial decision it is highly desirable to establish that the active drug is not only getting to the site of action but is also bio-available and having the expected impact on a relevant biochemical pathway.

By leveraging our expertise in immunology, skin biology, microbiology, and tissue engineering, we have helped many clients mitigate risk using performance models. These models are also known as pharmacokinetic/pharmacodynamic (PK/PD) models because they give a readout of where the drug permeates alongside a measure of biological activity.

MedPharm has used these PK/PD models to directly help clients:

Mitigate risk in programmes prior to making expensive clinical decisions

Inform API selection, dose ranges, posology, and formulation optimisation

Assess new targets and technologies for local activity

Achieve biowaivers for generics by showing equivalence with the originator product

Support marketing claims and educate key opinion leaders


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In vitro Disease Models

Price on request

When trying to de-risk a clinical trial decision it is highly desirable to establish that the active drug is not only getting to the site of action but is also bio-available and having the expected impact on a relevant biochemical pathway.

By leveraging our expertise in immunology, skin biology, microbiology, and tissue engineering, we have helped many clients mitigate risk using performance models. These models are also known as pharmacokinetic/pharmacodynamic (PK/PD) models because they give a readout of where the drug permeates alongside a measure of biological activity.


MedPharm has used these PK/PD models to directly help clients:

Mitigate risk in programmes prior to making expensive clinical decisions

Inform API selection, dose ranges, posology, and formulation optimisation

Assess new targets and technologies for local activity

Achieve biowaivers for generics by showing equivalence with the originator product

Support marketing claims and educate key opinion leaders


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Process and Scale-Up Chemistry

Price on request

Our process development experts are uniquely placed to predict and mitigate risks during the scale-up of the formulation. This is critical to achieving consistent product performance and quality at a stage of fundamental importance on the road towards commercialisation.

Process development aims to establish optimal manufacturing conditions for a pharmaceutical product and ensure that it meets both quality and regulatory standards. MedPharm’s long experience in scale-up has shown that investigating early in understanding the process can prevent potentially expensive issues occurring during the supply of clinical batches and also when starting commercial supply.

MedPharm uses the Quality by Design (QbD) principles outlined in ICH Q10 in the design and scale-up of any formulation. Combining an understanding of a product’s Quality Target Product Profile (QTPP) and subsequent Critical Quality Attributes (CQAs) with MedPharm’s many years of experience our scale-up team will recommend an efficient set of small scale experiments to test the sensitivity of the product to any Critical Process Parameters (e.g. mixing rate, cooling rate etc) they have identified. The data maps out any critical limits of these parameters and ensures that subsequent batches can be made with consistent quality.



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ICH Stability Testing

Price on request

Stability indicating methods are established early in the development process and can be appropriately validated for full-scale batch testing.

In order to simplify the compilation of a client’s regulatory submissions, all data is provided in IMPD/IND/CTD format. MedPharm can do stability testing in all ICH zones.


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Semisolid Manufacturing

Price on request

MedPharm manufacture batches for toxicology testing and clinical trials and can create registration batches for generic submissions. At this point the MedPharm team will be very familiar with the formulation and continuing to full-scale manufacture within the same team eliminates any potential for continuity errors that could impact a project’s commercial milestones.

Our teams have significant experience in filling, packaging, labelling and despatch of all formulation types, ensuring they are ready for use in clinical trials worldwide. Investigational product management services offered by MedPharm ensure an end-to-end service which complements the client’s clinical research activity.

Our GMP accredited facilities are capable of manufacturing all topical formulation types including liquids and semi-solids in batch sizes up to 100 kg.


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In vitro Bioavailability/Bioequivalence Studies

Price on request

The regulatory landscape for generic topical products has significantly evolved in recent years. Opportunities are opening in the USA and Europe for generic approvals by demonstrating in vitro bioequivalence, as opposed to utilising the risky and expensive clinical bioequivalence route.


MedPharm has led the way in pioneering this approach. We support our clients by producing credible data and presenting reliable arguments to regulatory authorities during scientific advice and pre-ANDA meetings.


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Analytical Method Development

Price on request

MedPharm will develop all necessary analytical methods applicable to the API, experimental matrix, formulation type, and presentation.

MedPharm’s philosophy is to try and develop the minimum number of methods for conducting forced degradation studies and stability-indicating methods. This is necessary to combine the detection of impurities and key excipients wherever possible. These methods will be validated to the appropriate level depending on the development stage of the project.

MedPharm looks to provide analytical data in the most appropriate visual presentation to aid client’s communication internally, with potential investors and when educating key opinion leaders.

To support formulation development MedPharm has sophisticated equipment for:

- measuring particle size and rheological properties

- predicting physical stability

- measuring drug concentrations to picogram/ml concentration using modern LC-MS instrumentation

- improving consistency and increasing throughput using a Hamilton Vantage robot


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Reverse Engineering

Price on request
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Buccal Absorption Studies

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Human Psoriasis-Like Epidermal Hyperplasia Model

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In vivo Skin Irritation/Sensitization Testing

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Daniel Morland

Senior Business Development Manager

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