-
Pharmacopsychiatry Jan 2018Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual... (Review)
Review
Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual variability of pharmacokinetics and thus enables personalized pharmacotherapy. In psychiatry and neurology, patient populations that may particularly benefit from TDM are children and adolescents, pregnant women, elderly patients, individuals with intellectual disabilities, patients with substance abuse disorders, forensic psychiatric patients or patients with known or suspected pharmacokinetic abnormalities. Non-response at therapeutic doses, uncertain drug adherence, suboptimal tolerability, or pharmacokinetic drug-drug interactions are typical indications for TDM. However, the potential benefits of TDM to optimize pharmacotherapy can only be obtained if the method is adequately integrated in the clinical treatment process. To supply treating physicians and laboratories with valid information on TDM, the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued their first guidelines for TDM in psychiatry in 2004. After an update in 2011, it was time for the next update. Following the new guidelines holds the potential to improve neuropsychopharmacotherapy, accelerate the recovery of many patients, and reduce health care costs.
Topics: Drug Monitoring; Guidelines as Topic; Humans; Mental Disorders; Neuropharmacology; Psychopharmacology; Psychotropic Drugs
PubMed: 28910830
DOI: 10.1055/s-0043-116492 -
Mini Reviews in Medicinal Chemistry 2016It has been over half a century since propranolol, the first beta-blocker, was developed for medical treatment. Since that time a large number of compounds from this... (Review)
Review
It has been over half a century since propranolol, the first beta-blocker, was developed for medical treatment. Since that time a large number of compounds from this group have been synthesised and many are now in clinical use. The structure, function, pharmacokinetics, and mechanism of beta-blockers have been established. The possibilities for their use in treating different conditions continue to evolve. Since the discovery of later generation beta-blockers, such as carvedilol and nebivolol, the search for new compounds continues, and may include known substances with beta-blocking properties which could extend their therapeutic potential.
Topics: Adrenergic beta-Antagonists; Chemistry, Pharmaceutical; Glaucoma; Humans; Hypertension; Hyperthyroidism; Migraine Disorders; Molecular Structure
PubMed: 26471965
DOI: 10.2174/1389557515666151016125948 -
Brain Research Bulletin Sep 2016Ayahuasca is the Quechua name for a tea obtained from the vine Banisteriopsis caapi, and used for ritual purposes by the indigenous populations of the Amazon. The use of... (Review)
Review
Ayahuasca is the Quechua name for a tea obtained from the vine Banisteriopsis caapi, and used for ritual purposes by the indigenous populations of the Amazon. The use of a variation of the tea that combines B. caapi with the leaves of the shrub Psychotria viridis has experienced unprecedented expansion worldwide for its psychotropic properties. This preparation contains the psychedelic 5-HT receptor agonist N,N-dimethyltryptamine (DMT) from P. viridis, plus β-carboline alkaloids with monoamine-oxidase-inhibiting properties from B. caapi. Acute administration induces a transient modified state of consciousness characterized by introspection, visions, enhanced emotions and recollection of personal memories. A growing body of evidence suggests that ayahuasca may be useful to treat substance use disorders, anxiety and depression. Here we review the pharmacology and neuroscience of ayahuasca, and the potential psychological mechanisms underlying its therapeutic potential. We discuss recent findings indicating that ayahuasca intake increases certain mindfulness facets related to acceptance and to the ability to take a detached view of one's own thoughts and emotions. Based on the available evidence, we conclude that ayahuasca shows promise as a therapeutic tool by enhancing self-acceptance and allowing safe exposure to emotional events. We postulate that ayahuasca could be of use in the treatment of impulse-related, personality and substance use disorders and also in the handling of trauma. More research is needed to assess the full potential of ayahuasca in the treatment of these disorders.
Topics: Animals; Banisteriopsis; Carbolines; Humans; Neurosciences; Pharmacology; Plant Extracts
PubMed: 26976063
DOI: 10.1016/j.brainresbull.2016.03.002 -
The AAPS Journal Jul 2014This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality... (Review)
Review
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.
Topics: Chemistry, Pharmaceutical; Drug Design; Drug Industry; Humans; Pharmaceutical Preparations; Quality Improvement; Technology, Pharmaceutical
PubMed: 24854893
DOI: 10.1208/s12248-014-9598-3 -
Therapeutic Delivery Jul 2023The effectiveness of pharmaceutical drugs depends not only on their active components and manufacturing processes, but also on the role played by pharmaceutical... (Review)
Review
The effectiveness of pharmaceutical drugs depends not only on their active components and manufacturing processes, but also on the role played by pharmaceutical excipients. The traditional definition of excipients as inactive and cost-effective substances has evolved significantly. They are now recognized as essential elements of drug formulations, constituting 80-90% of the final product. The rapid advancements in delivery systems, along with scientific, regulatory, financial and technological developments in biopharmaceutics, have generated renewed interest in the use and functionality of excipients, especially in solid dosage forms. This review focuses on the categorization of excipients according to the International Pharmaceutical Excipient Council (IPEC) and the establishment of guidelines for evaluating the safety of a new proposed excipient.
Topics: Excipients; Chemistry, Pharmaceutical; Drug Compounding; Biopharmaceutics; Pharmaceutical Preparations
PubMed: 37464784
DOI: 10.4155/tde-2023-0026 -
Journal of Pharmaceutical Sciences Jun 2023N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development and quality evaluation. Initial reports of nitrosamine...
N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development and quality evaluation. Initial reports of nitrosamine contamination were linked with the drug substance and its manufacturing process. Subsequently, the drug product and aspects of the formulation process have shown to be relevant. Regarding specific formulation contributions to nitrosamine content in a product, one risk lies in possible interactions between nitrosating agents, derived from nitrite in excipients, and vulnerable amines, either present as moieties of the active molecule or as impurities / degradants. However, the limited validated information on nitrite levels in excipients available until now, has been an obstacle for scientists to assess the risk of nitrosamine formation in pharmaceutical products. This has driven the creation of a database to store and share such validated information. The database, maintained by Lhasa Limited, constitutes a central platform to hold the data donated by the pharmaceutical company members on the nitrite concentrations in common excipients measured with validated analytical procedures. The goal of this data sharing initiative is to provide a common framework to contextualize and estimate the risk posed by presence of nitrites to contribute to the formation of nitrosamines in drug products. The major findings from the database analyses are: (1) average nitrite content and batch to batch variance differ among excipients, (2) for solid dosage forms, the nitrite contribution is dominated by the highest formula % excipients, e.g., the fillers (diluents), which are typically used in larger proportion, and are characterized by low nitrite levels and low variability, leading to an average value of 1 µg/g nitrite in a typical formulation, (3) substantial differences in average nitrite content in batches from different excipient vendors potentially reflecting differences in source materials or processing methods for excipient manufacturing. That final point suggests that future selection of raw materials or processing by excipient manufacturers may help reduce nitrite levels in finished drug product formulations, and thus the overall risk of nitrosamine formation in cases where the product contains vulnerable amines.
Topics: Nitrites; Nitrosamines; Excipients; Chemistry, Pharmaceutical; Amines; Risk Assessment
PubMed: 35500671
DOI: 10.1016/j.xphs.2022.04.016 -
Nordic Journal of Psychiatry Sep 2018Ethnopharmacology relates to the study of substances used medicinally by different ethnic or cultural groups or handling of, drugs-based ethnicity or pharmacogenetics. (Review)
Review
BACKGROUND
Ethnopharmacology relates to the study of substances used medicinally by different ethnic or cultural groups or handling of, drugs-based ethnicity or pharmacogenetics.
AIMS
To review the key aspects of ethnopharmacology.
METHOD
This lecture gives an overview of the relationship between geography, culture, pharmacogenomics and prescribing.
RESULTS
Although the majority of antipsychotics, antidepressants and mood-stabilisers are widely and cheaply available in generic forms, prescription rates can vary. Clozapine is one such example with prescribing-rates ranging from less than 10 patients per 100,000 people to nearly 180 patients/100,000 people. Pharmacogenetic studies of antipsychotics and antidepressants concern gene polymorphisms that may affect both, pharmacodynamic or pharmacokinetic properties. Considerable genetic and ethnic variability has been seen for the P450 microsomal enzymes CYP 2D6 and 1A2.
CONCLUSIONS
With accelerated global mobility and increased understanding of medicinal substances at molecular level, understanding of ethnopharmacology will become increasingly important in routine clinical practice.
Topics: Ethnopharmacology; Humans; Pharmacogenetics; Polymorphism, Genetic
PubMed: 30688173
DOI: 10.1080/08039488.2018.1525636 -
The American Journal of Psychiatry Feb 2022
Topics: Attention Deficit Disorder with Hyperactivity; Comorbidity; Humans; Psychopharmacology; Psychotherapy; Substance-Related Disorders
PubMed: 35105160
DOI: 10.1176/appi.ajp.2021.21121218 -
Medizinische Monatsschrift Fur... Jan 2017Despite unmet meeds regarding efficacy, tolerability and time of onset and the high importance of mental disorders very few new psychotropics have been introduced in... (Review)
Review
Despite unmet meeds regarding efficacy, tolerability and time of onset and the high importance of mental disorders very few new psychotropics have been introduced in Germany recently. Lurasidon and the new multimodal antidepressant vortioxetine demonstrating clinical efficacy in the improvement of cognition have been withdrawn from the German market due to economic reasons based on an official committee judgement „missing additional benefit“. Among new substances introduced are the selective opioid modulator nalmefene for reduction of alcohol consumption, the selective alpha-2-receptor agonist guanfacine for ADHS treatment in child and youth psychiatry, the older antidepressant milnacipran and the glucagon-like-peptide-1-receptor agonist liraglutide for treatment of adipositas. In the USA the atypical antipsychotics cariprazine and brexpiprazole have been released. The introduction of the long acting depot antipsychotics aripiprazole (1 month) and paliperidone (3 months) can be seen as major progress in the treatment of schizophrenia. Loxapine is available as inhalative antipsychotic for rapid treatment of agitation in schizophrenia and mania. Atypical antipsychotics like quetiapine are recommended now as add-on treatment for therapy-resistant depressions. Ketamine and botulinum toxin are in experimental use as antidepressants. The development of psychotropics is long lasting and costly and made even more difficult by negative medial attitudes additionally. Constructive resolving attempts are needed urgently to avoid a standstill in the development of psychotropic drugs.
Topics: Antidepressive Agents; Antipsychotic Agents; Humans; Mental Disorders; Psychopharmacology; Psychotropic Drugs
PubMed: 29952523
DOI: No ID Found -
Profiles of Drug Substances,... 2016Calcium carbonate is a chemical compound with the formula CaCO3 formed by three main elements: carbon, oxygen, and calcium. It is a common substance found in rocks in... (Review)
Review
Calcium carbonate is a chemical compound with the formula CaCO3 formed by three main elements: carbon, oxygen, and calcium. It is a common substance found in rocks in all parts of the world (most notably as limestone), and is the main component of shells of marine organisms, snails, coal balls, pearls, and eggshells. CaCO3 exists in different polymorphs, each with specific stability that depends on a diversity of variables.
Topics: Animals; Antacids; Calcium Carbonate; Chemistry, Pharmaceutical; Humans
PubMed: 26940168
DOI: 10.1016/bs.podrm.2015.11.003