The authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.
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Sample preparation before analysis is just as important as the analytical technique because poor sample preparation alters or skews the analytical result.
When drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
Monoclonal antibodies and recombinant proteins have increased their importance and gained success as therapeutic agents in the treatment of various diseases.
The authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology.
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.
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.
For true freeze-drying cycle optimisation, information on the maximum allowable product temperature during primary drying is required.
...an uninformed decision based on commercial requirements alone may, ultimately, have disastrous consequences on the efficacy of the target recombinants.
When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.
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.
Understanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.
A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.
How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?
Different chemistries and viscosities of HPMC can be combined to modulate release profile and, in some cases, result in a more robust formulation.
Monoclonal antibodies and recombinant proteins have increased their importance and gained success as therapeutic agents in the treatment of various diseases.
The addition of superdisintegrants to oral solid dosage forms can improve disintegration and, in turn, drug dissolution.
A CRO and a client company must plan strategically together to minimize and prevent possible project roadblocks.
A summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
A novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
The pharmaceutical industry must address the release of nonbiodegradable APIs into the environment.
A recent USP gathering generated creative suggestions for the March 2005 USP convocation.
With pressure to cut costs, shorten the pipeline life cycle and maximize return on investment, pharmaceutical manufacturers need tools that help them improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing.
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.