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Biomedical subjects

M Spino

Publications and source records attributed to M Spino.

41 records · Page 3Linked to original sources
PubMedDate not supplied

Human platelet response to three salicylate dosage forms.

Acetylsalicylic acid (ASA) inhibition of platelet aggregation as evaluated by collagen-induced 14C-serotonin release, has been measured in 12 healthy male subjects. Each subject received a single oral dose (650 mg) of enteric-coated ASA (ecASA) and compressed ASA tablets (cASA), or ecASA and sodium salicylate (578 mg) separated by a minimum of 5 weeks. The platelet response was related to plasma ASA and salicyclic acid determined by high-pressure liquid chromatography. Both ecASA and cASA inhibited 14C-serotonin release; no significant difference was observed in the maximum effect between these two products (p less than 0.05). No relationship was found between the maximum observed plasma ASA level and the maximum effect. Further, no correlation was found between the maximum inhibition of 14C-serotonin release in vivo and the release predicted from in vitro experiments wherein the effect was measured after incubating plasma containing specified ASA concentrations.

Adult↗
PubMedDate not supplied

Pharmacokinetics of drugs in cystic fibrosis.

Considerable work has been conducted on patients with CF to clearly demonstrate enhanced clearances of many, but not all drugs. The precise mechanisms for enhanced drug clearance in CF remain to be elucidated, and it will be important to examine the two major organs of drug elimination, the kidney and liver, for answers to these questions. Although it has not been studied to date, the role of the lung as a contributor to enhanced drug clearance in CF needs to be considered as well. In the liver it appears that both hepatic biotransformation as well as biliary excretion may be enhanced. In the kidney, there is enhanced CL of acidic drugs, but variable findings for cationic and zwitterionic drugs. The latter finding can be explained on the basis of the pKa of the drugs and the urine pH. It would be most appealing if enhanced renal and nonrenal clearance of drugs in CF could be attributed to a common single defect. At this time, there is no obvious candidate, although altered transmembrane transport would represent a place to start.

Cystic Fibrosis↗
PubMedDate not supplied

Dissolution and in vivo evidence of differences in reference products: impact on development of generic drugs.

The WHO List of International Comparator Pharmaceutical Products (CPP) For Equivalence Assessment of Interchangeable Multi-Source (Generic) Products will address an important issue in developing new generic drugs because it will identify the 'correct' reference product. This list will reduce unnecessary clinical studies in jurisdictions requiring new generics to be compared with brand products sold locally. Eventually, by employing the CPP, there will be a world-wide standard for brand and generic drugs, assuring the same level of quality internationally. The strategy of a single global reference is meritorious, but there are several hurdles to overcome. Most important is that the same brand may differ in dissolution and/or bioavailability in various jurisdictions, including some drugs with a narrow therapeutic index like phenytoin. Several examples are provided in this manuscript. This issue of regional differences has relevance, not only to the WHO list, but also to the matter of how safety and efficacy was established for that product in the first place. Normally, phase III clinical studies are conducted on a product manufactured in a single site, set to one standard. If the product differs in bioavailability in different jurisdictions, one is left with the question: 'which product has remained true to the original formulation?' Alternatively, if safety and efficacy is maintained with all formulations, then one is faced with the question: 'are the criteria currently employed for bioequivalence unnecessarily restrictive?'

Drug Industry↗
PubMedDate not supplied

Neonatal withdrawal syndrome: associated drugs and pharmacologic management.

Use of addicting drugs among women during pregnancy exposes newborns to potentially serious disorders. A group of symptoms referred to as neonatal withdrawal syndrome (NWS) may occur in infants born to mothers addicted to certain drugs because, at birth, the infants suddenly are cut off from the drug supply. Classes of drugs that cause NWS are those that produce addiction in adults, including the opioids (heroin, methadone, morphine), barbiturates, alcohol, and benzodiazepines. Many of the manifestations of NWS occur regardless of the class of drug, including irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, weight loss, and failure to gain weight. The fact that these symptoms are nonspecific makes it difficult to identify NWS unless it is specifically looked for. The onset, duration, and severity of the disorder differ based on such factors as the addictive drug used, time and amount of mother's last dose, and rate of elimination of the drug from the newborn. Pharmacologic intervention may be required to control severe symptoms and signs. The most common drugs used to modify withdrawal are phenobarbital, paregoric, chlorpromazine, and diazepam. Treatment is complicated by conflicting information on the effectiveness of various agents.

Barbiturates↗