Glossary
A | B | C | D | E | F | G | H | I | L | M | N | O | P | S | T
| A | ||
| API: | active pharmaceutical ingredient. | |
| Apomorphine hydrochloride: | a type of dopaminergic agonist or a morphine derivative that does not actually contain morphine. Apomorphine is currently used in the treatment of Parkinson's disease and erectile dysfunction. | |
| Asthma: | a condition in which individuals suffer from a widespread narrowing of the bronchial airways, which changes in severity over short periods of time, leading to cough, wheezing and difficulty in breathing. | |
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| B | ||
| Beclometasone: | a steroid that is used to help prevent the symptoms of asthma. | |
| Bioavailability: | the extent to which a drug is absorbed into the bloodstream. | |
| Blending: | blending with lactose improves aerosol performance, providing optimal deaggregation, reliable metering and accurate dosing. The active drug molecules sit on the surface of the lactose; once inhaled the drug particles detach from the lactose and flow into the lower airways, and the lactose hits the back of the throat and is swallowed. | |
| Bronchodilator: | a drug that relaxes and dilates the bronchial passageways and improves the passage of air into the lungs. Bronchodilators help breathing and relieve asthma symptoms but not inflammation. | |
| Budesonide: | a steroid thatich is used to help prevent the symptoms of asthma. | |
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| C | ||
| COPD: | chronic obstructive pulmonary disease is an irreversible and chronic obstruction of the airways, caused primarily by smoking. Conditions of COPD include chronic bronchitis and emphysema, sometimes both. The disease progresses and eventually leads to a largely irreversible loss of lung function. | |
| Cystic fibrosis: | a genetic disease involving a sticky build-up of mucus in the lungs (which makes breathing difficult and leads to infections) as well as pancreatic insufficiency (which leads to digestive problems). | |
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| D | ||
| Diabetes: | a chronic health condition where the body is unable to produce or adequately use insulin. Symptoms include thirst, excessive urination, dehydration and weight loss. The treatment of diabetes may require daily insulin injections, proper nutrition and regular exercise. | |
| DPI: | dry powder inhaler. | |
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| E | ||
| Erectile dysfunction: | (or impotence) is a sexual dysfunction characterised by the inability to develop or maintain an erection. There are various underlying causes, such as diabetes, many of which are medically reversible. | |
| Excipient: | an inactive ingredient added to a drug (i.e. in pill form) to dilute it or to give it form, consistency or stability. | |
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| F | ||
| Factor VIII: | an essential factor necessary for blood to clot. The lack of normal Factor VIII causes haemophilia A, an inherited bleeding disorder. | |
| FDA (Food and Drug Administration): | part of the US Department of Health and Human Services Agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. | |
| Fibrinogen: | a protein used in coagulation. It reacts with other molecules to produce blood clots. | |
| Formoterol: | belongs to the family of medicines known as beta-2 agonists. It is used to help treat or relieve the symptoms of asthma. | |
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| G | ||
| GCP (Good Clinical Practice): | the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. | |
| GLP (Good Laboratory Practice): | a compliance-monitoring programme, through laboratory inspections and data audits, which assures the quality and integrity of test data. | |
| GMP (Good Manufacturing Practice): | a European standard required by companies that produce pharmaceuticals and medical devices and which is administered and monitored in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). | |
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| H | ||
| Haemophilia A: | a disorder of the blood in which it lacks an agent, known as Factor VIII, to make it clot. | |
| Hyaluronic acid: | a natural component of connective tissue, including the skin, which plays a critical role in providing volume to skin by retaining water. It may be manufactured by bacterial fermentation. | |
| Hypomobility: | a decrease in the normal range of joint movement. | |
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| I | ||
| Icodextrin: |
is a high molecular weight starch-like molecule that may be used in solution to act as a peritoneal dialysate or as a means to reduce post-surgical adhesion formation. | |
| IND or Investigational New Drug: | an IND is the authorisation from the FDA to administer a new drug to humans in clinical trials. | |
| L | ||
| Lactose: | a type of sugar found in milk and milk products. | |
| M | ||
| Macromolecules: | large molecules in biological systems, namely proteins, nucleic acids and polysaccharides. | |
| Meptin® (procaterol): | a beta-2 agonist developed by Otsuka used to treat the symptoms of asthma, chronic bronchitis, emphysema, and other lung diseases. | |
| MHRA: | Medicines and Healthcare Products Regulatory Agency. | |
| Micron: | one thousandth of a millimetre. | |
| Micronisation: | the process in which the active ingredient of a drug is milled to microscopic size by particle to particle collision. At this point the drug particles become highly cohesive and will not flow or disperse easily and need to be blended. | |
| Migraine: | A headache characterised by throbbing head pain, often greater on one side; may be preceded by a warning (aura) and accompanied by nausea, vomiting, and sensitivity to light and sound; in rare cases, weakness, language problems, or other neurologic disorders are associated with migraine. | |
| Muscarinic antagonist: | is a long-acting anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). | |
| Mutual Recognition Procedure: | a marketing authorisation for a pharmaceutical product in more than one country in the European Union. It may be applied for through one of three procedures: the Centralised Procedure, the Mutual Recognition Procedure (MRP), or the Decentralised Procedure. | |
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| N | ||
| NCE: | a New Chemical Entity, or new drug. | |
| O | ||
| Orphan Drug Status: | Orphan Drug Status may be granted to a drug by the Office of Orphan Products Development in the US or the European Medicines Agency (EMEA) in Europe. It is designed to encourage the development of drugs that are necessary but would be prohibitively expensive/unprofitable to develop under normal circumstances and provides tax incentives and other advantages to companies engaged with the development of such drugs. | |
| P | ||
| Parkinson’s disease: | a progressive disorder of the nervous system marked by muscle tremors, muscle rigidity, decreased mobility, stooped posture, slow voluntary movements, and a mask-like facial expression. | |
| Peptide: | a molecule composed of two or more amino acids. Larger peptides are generally referred to as polypeptides or proteins. An amino acid is any class of 20 molecules that are combined to form proteins in living things. The sequence of amino acids in a protein and hence protein function are determined by the genetic code. | |
| Peritoneal: | of the peritoneum, which is the membrane that forms the lining of the abdominal cavity. | |
| Phase I: | a clinical trial that includes the initial introduction of an investigational new drug or IND into humans. Phase I trials are typically closely monitored and may be conducted in patients or normal volunteer subjects. These trials are designed to determine the metabolism and pharmacology of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness. During Phase I, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase II trials. The total number of subjects and patients included in Phase I trials varies with the drug, but is generally in the range of 20–80. | |
| Phase II: | a clinical trial that includes controlled clinical activities conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. Phase II trials are typically well controlled, closely monitored and conducted in a relatively small number of patents, usually involving no more than several hundred subjects. | |
| Phase III: | clinical trials performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit–risk relationship of the drug and to provide an adequate basis for physician labelling. Phase III trials usually include from several hundred to several thousand subjects. | |
| Polyol stabilisation: | may be used to stabilise peptides and proteins. The incorporation of trehalose into a dry powder formulation utilising spray drying or foam drying offers the potential of room temperature stability to the resulting formulation, avoiding the need for refrigerated storage. | |
| Premature ejaculation: | sexual dysfunction characterised by the inability to control or delay ejaculation as long as desired. | |
| Proof-of-principle: | a study that demonstrates an effect that results in a biological change that is closely related to the proposed mechanism of action and known to be associated with disease activity in patients. Proof-of-principle can also be carried out in patients or healthy volunteers using appropriate challenge agents provided that a clear link can be established between the effect and the target disease. | |
| Protein: | a molecule composed of a long chain of amino acids. Proteins are the principal constituents of cellular material and serve as enzymes, hormones, structural elements, and antibodies. The molar mass of a protein is usually above 100,000. | |
| Pulmonary controlled release: | uses oligosaccharide ester derivatives (a modified carbohydrate matrix) or hyaluronic acid encapsulation of the active pharmaceutical ingredient to enable controlled drug release within the lung. The powder formulations that combine the active drug and the excipient controlling the rate of release are obtained through the use of spray drying. | |
| Pulmonary hypertension: | high blood pressure in the blood vessels of the lungs, which if left untreated may lead to heart failure. | |
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| S | ||
| Salbutamol: | a beta-2 agonist used to treat wheezing, shortness of breath and troubled breathing caused by asthma, chronic bronchitis, emphysema and other lung diseases. | |
| Spray drying: | applicable to a wide range of materials and may be used for macromolecules, e.g. proteins and peptides, as well as small molecules. The process gives control over target particle characteristics important for pulmonary drug delivery and produces particles designed for better, deeper lung delivery. In addition, the inclusion of non-active excipients such as trehalose or hyaluronic acid can stabilise and alter the kinetics of the active pharmaceutical ingredient. Spray drying is also suitable for the preparation of other solid dose formats. | |
| T | ||
| Thrombin: | an enzyme that converts fibrinogen to fibrin. | |
| Trehalose: | a disaccharide or sugar found in invertebrates, bacteria, algae and fungi that may be used to stabilise protein structures. | |
