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Practical Solutions for Poorly Soluble Drugs

Aesica
29 May 2014

The therapeutic efficacy of a drug depends upon its bioavailability, which is directly correlated to its solubility. Many drugs, both in development and on the market, are poorly soluble in aqueous media, which can lead to poor bioavailability, and frequently results in variable dissolution rates. To achieve the desired drug concentration in systemic circulation to elicit a pharmacological response, solubility is paramount. Yet, less than 10% of new drug candidates demonstrate both high solubility and permeability, and 30–40% of the drugs that appear on the World Health Organisation (WHO) Essential Drug List were reported to be poorly water-soluble or lipophilic, based on the Biopharmaceutics Classification System (BCS). This whitepaper discusses laboratory scale formulation expertise and equipment in three distinct technologies.

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Aesica Formulation Development Service

Aesica

Formulation Development SpecialistsWith a keen understanding of early stage development and clinical trial requirements, Aesica guides their customers through the processes of new medicine and material development for Phase 1 and Phase 2 clinical trials. They understand that their customers also need to maximise their budget effectiveness by minimising the amount of experimentation without sacrificing quality levels.Typical dosage forms we work with include tablets, capsules, liquids, suspensions, creams, ointments, inhaled and sterile pharmaceuticals. Aesica offer a suite of formulation development services… Pre-formulation Formulation and manufacturing Analysis and stability testing Manufacturing of clinical trial materials Regulatory support Technology transfer Aesica Formulation Development Service Benefits: Working with a fast-growing UK company with an expanding international presence Working with a flexible, dynamic, innovative organisation Working with full service development and manufacturing capability – from process development to commercial scale manufacture Working with a partner who can be trusted to deliver the highest standards in all areas: consultation, development, manufacture and delivery

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Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Drug DosageDosage is the size or frequency of the administration of a drug. Determination of the dosage of a drug is critical in pharmaceutical development to ensure the optimum balance between efficacy and toxicity.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.

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Practical Solutions for Poorly Soluble Drugs