The use of lipid-based dosage forms for enhancement of drug absorption or delivery has drawn considerable interest from pharmaceutical scientists. The unique characteristics of these dosage forms, however, present significant challenges to pharmaceutical industry and regulatory agencies in many ways. For example, safety assessment is necessary when the use of a new lipid excipient is considered...

OBJECTIVE To compare advice on dosage adjustment for renal impairment provided by four commonly used secondary pharmacotherapeutic sources. DESIGN Systematic comparison of the definitions of renal impairment, recommendations for dosage adjustment, and the evidence in support of these recommendations in four information sources. DATA SOURCES British National Formulary, Martindale: the Comple...

The various approaches to increase the gastric residence of dosage forms are: effervescent single/multiple unit dosage forms, non-effervescent single/multiple unit dosage forms, high density dosage forms, expandable systems, swelling systems, unfolding systems, and adhesionmucoadhesive systems. The floating drug delivery systems of this class contains one or more gel forming swellable cellulose...

Development of controlled release transdermal dosage form is a complex process involving extensive research. Transdermal patches have been developed to improve clinical efficacy of the drug and to enhance patient compliance by delivering smaller amount of drug at a predetermined rate. This makes evaluation studies even more important in order to ensure their desired performance and reproducibil...

In recent years, the clinical research business developed extremely fast in emerging countries such as China, India and Philippines, mainly because of increased high investigation fees in western countries. Specifically in China, an additional portion of drug applications falls under the area that requires bioequivalence study or clinical trials due to the amendment of the Drug Registration Reg...

patient noncompliance to current tuberculosis (tb) therapy owing to multidrug administration daily leads to treatment failure and emergence of multidrug resistant and extensively drug resistant tb. to avoid the daily dosing, application of nanotechnology is the only viable solution by virtue of sustained release of drugs. other potential advantages of the system include the possibility of selec...

System-approach based modeling methods are used to model dynamic systems describing in vitro dissolutions of drug dosage formulations. Employing the models of these systems, model-dependent criteria are proposed for testing similarity between in vitro dissolutions of different drug dosage formulations. The criteria proposed are exemplified and compared with the criterion called the similarity f...

In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/novel dosage forms that represented the scientific opinions of many experts in the field at that time (1). The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and...

Strategies involving new applications of existing drugs are urgently needed to reduce the time required to cure patients with drug-susceptible and drug-resistant tuberculosis (TB). Use of high-dosage rifampicin is one such approach. Recent data from preclinical animal models (Hu et al., 2015) and clinical studies (Boeree et al., 2015) support a potential role for highdosage rifampicin in TB che...

Oral delivery of drugs is by far the most preferable route of drug delivery . Oral-rate controlled drug delivery systems have an important area among novel drug delivery system. But these oral sustained release drug delivery systems suffer greatly due to their short gastric residence time/ gastric emptying time. Whereas prolonged gastric residence increases duration of drug release, reduces dru...