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Dropping Method Solution for Formulating Solid DispersionsThe use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.
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Coming to Terms with ComplianceThe pressure on the pharmaceutical industry to manufacture products faster and more cost-effectively has never been greater. Additionally, companies must also meet stringent regulations set by authorities such as the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). This article explores the importance of complying with regulations and validation, how to maintain compliance and looks at some of the consequences of non-compliance.
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Synthetic Excipients Challenge All-Natural OrganicsSynthetic excipients frequently offer advantages over all-natural compounds.
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Improving Dose Content Uniformity Testing for MDIs and DPIsIt has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
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From the Formulator to the Tablet Manufacturing Floor: Desiderata and TroubleshootingTablet manufacturers often overlook critical basic concepts or established practices. The author draws from his own experiences and discusses how solid dosage manufacturers can improve production and product quality by optimizing major unit operations.
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Particle Engineering for Improved Dispersion in Dry Powder InhalersRespirable drug delivery is becoming increasingly popular because it provides a non-invasive route with rapid drug uptake, not only for the treatment of respiratory complaints, but also for the systemic delivery of substances that cannot be delivered orally.
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The Granulation Process 101: Basic Technologies for Tablet MakingThe author offers a primer for choosing the correct granulation process to improve yields, reduce tablet defects, and enhance productivity.
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Analytical Techniques for Oral Solid Dosage FormulationAnalytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.
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Aqueous Cleaning and Solvent Substitution in Chemical Synthesis API ManufacturingOrganic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.
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Certificates of Test - What are the European GMP Requirements?This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.
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Characterization of Polymeric ExcipientsThis article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.
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Integrated Compliance ManagementManufacturing exceptions and variability often can be managed more effectively through integrated, enterprise-wide systems.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Application of Cryogenics for Sustainable Solvent RecoveryEmissions control has long been a primary concern for the pharmaceutical processing industry in Europe, which relies on the use of a number of organic solvents for the manufacture of pharmaceutical products...
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Why Search Matters: Information Retrieval in the Pharmaceutical IndustryInformation retrieval (IR) deals the representation, storage, organization of unstructured applying natural-language processing,semantic relationships, linguistic analyses,behavioral histories, and “fuzzy” statistical techniques to help human quickly find and retrieve the information they seek.
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The Relationship between Saturated Hydrogen Peroxide, Water Vapour and TemperatureHydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.
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Experimental and computational methods for understanding pharmaceutical flows, Part II: Large-scale production equipmentFlow problems, such as process performance and reliability, can be improved using a combination of experimental and computational methods.
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A Risk-Management Approach to Cleaning-Assay ValidationThe authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.
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PhRMA Perspectives on Drug Substance Regulatory Filing IssuesThe PhRMA API Technical Group examines topics concerning active pharmaceutical ingredient development and manufacture and makes recommendations for regulatory guidance.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Benefits of Process Information Management in R&D - A Case StudyThis case study examines the benefits of introducing process information management software to a pharmaceutical pilot plant. The advantages illustrate the potential for process development and commercial manufacturing improvements that are available to the pharmaceutical industry.
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A Novel Compression-Coated Tablet Dosage FormThe authors modified a three-layer press to operate a compression-coated tablet process that may offer several advantages over tradditional compression coating operations.
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Studying In Vitro Skin Preparation and Drug Release to Optimize Dermatological FormulationsIn vitro skin penetration and drug-release studies are the simplest and most cost-effective methods for characterizing a drug's skin absorption and penetration profiles.
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The Usefulness of 0.45 µm–Rated Filter MembranesIn this study, the authors examine the suitability of 0.45 µm–rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.
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A Novel Amorphous Delivery System to the Skin for Poorly Soluble ActivesDrugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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Optimizing Cross-Organizational Team Performance and ManagementTreating a cross-organizational team as a full-fledged partnership helps complete a project on time and on budget.
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Excipient Quality EssentialsDefining quality for excipients may not be as clear cut as it is for APIs, but it is essential to product quality and patient safety, and to choosing the best supplier.
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A reliable method for producing highly purified water.This article describes the quality of highly purified water and its applications, addressing why ultrafiltration (UF) is being used as a downstream purification process. It aims to show that UV is a real alternative for producing pyrogen-free water. This method allows essential cost savings compared with distillation and guarantees a higher safety than other membrane methods such as reverse osmosis.
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ISO Standard for Primary Packaging MaterialsBased on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
