Manufacturing and Processing - Pharm Tech Europe
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May 12, 2008

Manufacturing and Processing
  • Current status in buccal drug delivery


    The adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required. The major obstacles of this drug delivery method are the extensive presystemic degradation processes in the gut and/or liver, resulting in inadequate or erratic absorption and low systemic bioavailability. The parenteral route is the only established way that overcomes these drawbacks, but it may not achieve the maintenance of adequate drug levels at the receptor for as long as it is needed, which results in it high costs, poor patient compliance — especially in long-term therapies — and various further inconveniences and risks. Moreover, it requires repeated administration and is potentially hazardous as rapid drug removal is unachievable.

    Getting the most out of producing therapeutic biologics


    Water, water everywhere?


    The amount of water used by industry, including pharma and biotech manufacturing, amounts to 23% of the world's supplies

    20th Anniversary Special Feature: Outsourcing biologics manufacturing


    Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.

    Making data analysis lean


    Six sigma, process analytical technology (PAT) and related initiatives are driving greater use of statistical analysis methods to increase process understanding and improve manufacturing capabilities.

    A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquids


    The stability of drugs in solid forms such as powders, tablets and capsules is usually determined very thoroughly by the drug's manufacturer. Based on stability study data, the shelf-life of a drug substance or a drug product is assigned. In addition to dispensing solid dosage forms to patients, pharmacists are frequently asked to compound oral liquid preparations for which the shelf-life or beyond-use date are assigned based on the pharmacist's best judgment — often without the benefit of stability data.

    20th Anniversary Special Feature: Two decades of packaging development


    Twenty years ago it was commonplace for pills, tablets and capsules to come in small, plastic or even glass bottles. Syrups were a much more common galenic solution than today, and individual dosages of injectables were only offered in glass vials and ampoules.

    Automation works


    My personal experience of lab automation is limited to supervising a peptide synthesiser back in the late 1980s. The machine was eye-wateringly expensive — but it was soon paying its way in terms of productivity and research publications. So if I were a stake-holder in a company pondering whether to invest in a well-designed gadget that could automate a routine operation, I'd say: 'go for it'.

    The challenge of 21st century influenza


    Conventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' — a critical factor that would arise in the event of a pandemic.

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