Decline in New Drug Launches: Myth or Reality? Retrospective Observational Study Using 30 Years of Data From the UK.

Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK.

BMJ Open. 2013; 3(2):
Ward DJ, Martino OI, Simpson S, Stevens AJ

To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.Retrospective observational study. SETTING AND DATA SOURCE: Database of new preparations added annually to the British National Formulary (BNF).The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11-12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective. HubMed – drug

 

Comparison of the anti-dopamine D2 and anti-serotonin 5-HT2A activities of chlorpromazine, bromperidol, haloperidol and second-generation antipsychotics parent compounds and metabolites thereof.

J Psychopharmacol. 2013 Feb 20;
Suzuki H, Gen K, Inoue Y

Second-generation antipsychotics, which have become the standard drug therapies for schizophrenia, are known to have a serotonin 5-HT(2A) receptor blocking effect in addition to a dopamine D(2) receptor blocking effect. However, although chlorpromazine (CPZ) has a 5-HT(2A) receptor blocking effect and has the profile of a second-generation antipsychotic in vitro, it loses this pharmacological profile in vivo. In order to elucidate the differences between the in vivo and in vitro pharmacological characteristics of CPZ, we used a radioreceptor assay to measure the anti-D(2) activity and the anti-5-HT(2A) activity of CPZ and five major metabolites of CPZ, and compared the results to the anti-D(2) activity and anti-5-HT(2A) activity of risperidone, zotepine, perospirone, the major metabolites of each of these drugs, and olanzapine, bromperidol, and haloperidol. The subjects were 182 patients who had received diagnoses of schizophrenia based on the DSM-IV criteria. The results revealed that CPZ exhibited little anti-5-HT(2A) activity, regardless of the anti-D(2) activity level, and that none of the metabolites possessed anti-5-HT(2A) activity. However, both the parent compounds and the metabolites of each of the second-generation antipsychotics possessed both anti-D(2) activity and anti-5-HT(2A) activity. This clarified that, unlike second-generation antipsychotics, the reason CPZ loses its second-generation antipsychotic profiles in vivo is because it does not have any metabolites that possess anti-5-HT(2A) activity. HubMed – drug

 

Improvement of Nanoprecipitation Technique for Preparation of Gelatin Nanoparticles and Potential Macromolecular Drug Loading.

Macromol Biosci. 2013 Feb 20;
Khan SA, Schneider M

An optimum nanoprecipitation technique for gelatin nanoparticles is established, based on aqueous gelatin solution and ethanolic solution containing stabilizer. Crosslinking with glutaraldehyde results in stable gelatine nanoparticles. Several factors such as the surfactant concentration, type of surfactant, type of nonsolvent and gelatin concentration are evaluated. Gelatin nanoparticles with 200-300?nm can be produced using 20-30?mg?mL(-1) of gelatin and a minimum of 7% w/v stabilizer (Poloxamer 407 or 188). Furthermore, methanol and ethanol are good nonsolvents, whereas other nonsolvents such as acetone, isopropyl alcohol, and acetonitrile, result in phase separation and visible precipitates. The entrapment efficiency of fluorescein-isothiocyanate (FITC)-dextran as model drug was determined to 50% with no substantial effect on particle size. 80% of the drug is only released after enzymatic digestion. HubMed – drug

 

Drug company gifts to medical students: the hidden curriculum.

BMJ. 2013; 346: f1113
Kesselheim AS

HubMed – drug

 

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