Abstract:
:Stability of a dosage form is its ability to preserve its quality attributes within preset limits. The time span over which these attributes remain within specifications is the shelf-life of the drug product. Stability is a very complex feature and is influenced not only by the stability of the drug substance but also by the stability of excipients and the interaction of the components within the system. Another important contributing factor is the packaging material, which is responsible for the protection of the drug product. Not only drug substances, but also excipients are susceptible to different degradation mechanisms. Amorphous polymers, a relatively frequently used group of excipients, are especially prone to physical instability. Through the process of physical ageing, a slow volume and enthalpy relaxation can be experienced, which can lead to remarkable alterations in solid dosage form properties. Functional changes within the solid dosage form associated with instability include changes in mechanical properties, homogeneity and drug release characteristics, discoloration, phase separation or changes in melting time of suppositories. Stability assessment is a crucial issue during formulation development, which is strictly regulated by authorities responsible for drug registration. The primary purpose of this paper is to give an overview of the different types of physical changes influencing solid state stability of dosage forms, and how such changes can be monitored. We will also illustrate how the quality of a solid dosage form varies with time under the influence of different environmental factors.
journal_name
Curr Pharm Desjournal_title
Current pharmaceutical designauthors
Szabó P,Zelko R,Antal Idoi
10.2174/1381612822666160726094236subject
Has Abstractpub_date
2016-01-01 00:00:00pages
5019-5028issue
32eissn
1381-6128issn
1873-4286pii
CPD-EPUB-77336journal_volume
22pub_type
杂志文章,评审abstract::Arrhythmias in left ventricular hypertrabeculation/noncompaction (LVHT) comprise sustained or non-sustained ventricular tachycardia (VT) (n=135), atrial fibrillation (AF) (n=96) AV block (n=55) and QT prolongation (n=47). The prevalence differs between children and adults. In children most frequent are WPW-syndrome (n...
journal_title:Current pharmaceutical design
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doi:10.2174/138161210793176518
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journal_title:Current pharmaceutical design
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journal_title:Current pharmaceutical design
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journal_title:Current pharmaceutical design
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abstract::Development of effective drug delivery systems is important for medicine and healthcare. Polymer particulates (micro- and nanoparticles) have opened new opportunities in the field of drug delivery by overcoming various limitations of conventional delivery methods. The properties of polymeric particles can be readily t...
journal_title:Current pharmaceutical design
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abstract::Ablation has become an important treatment for many pediatric patients with common supraventricular tachycardias (SVTs). Many multicenter studies have documented that radiofrequency (RF) catheter ablation is a safe and effective procedure for treatment of a large variety of SVTs in children and adults with a high succ...
journal_title:Current pharmaceutical design
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journal_title:Current pharmaceutical design
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abstract:BACKGROUND:Loss of olfaction can cause noticeable reduction in general quality of life. Only a small portion of patients with olfactory loss respond to current medications. Thus, development of novel therapeutic strategies seems to be necessary. Looking into traditional medical knowledge can be of great value in addres...
journal_title:Current pharmaceutical design
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journal_title:Current pharmaceutical design
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abstract::All common contributing factors to epilepsy such as trauma, malignancies and infections are accompanied by different levels of central nervous system inflammation that in turn have been associated with the occurrence of seizure. Emerging data from human brain tissue and experimental models of epilepsy support the prop...
journal_title:Current pharmaceutical design
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更新日期:2013-01-01 00:00:00
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journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
doi:10.2174/1381612003400245
更新日期:2000-05-01 00:00:00
abstract::Atherosclerosis is an inflammatory vascular disease that is characterized by progressive accumulation of cholesterol in the arterial walls and it is a major cause of cardiovascular disease. Issues related to the side effects of synthetic drugs have in recent times, led to the misuse of drugs, a lack of patient consult...
journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
doi:10.2174/1381612824666180911121525
更新日期:2018-01-01 00:00:00
abstract::Angiotensin-converting enzyme (ACE) inhibitors represent one of the most commonly used categories of drugs in canine and feline medicine. ACE inhibitors currently approved for use in veterinary medicine are benazepril, enalapril, imidapril and ramipril. They are all pro-drugs administered by oral route. A physiologica...
journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
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更新日期:2007-01-01 00:00:00
abstract::Cyclooxygenase-1 (COX-1) derived eicosanoids promote gastroprotective mucosal defenses and induce platelet aggregation. By sparing COX-1, COX-2 specific inhibitors provide effective anti-inflammatory and analgesic activity while substantially reducing the risk of peptic ulcer disease and GI bleeding compared to dual C...
journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
doi:10.2174/1381612033454018
更新日期:2003-01-01 00:00:00
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journal_title:Current pharmaceutical design
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doi:10.2174/1381612822666160518141911
更新日期:2016-01-01 00:00:00
abstract::G protein receptor kinase 2 (GRK2) has been for years mainly considered the negative regulator of the cardiac β adrenergic signaling. However GRK2 is a ubiquitous molecule and its kinase activity and scaffold properties brought to several investigations which have evidenced its involvement in pathophysiology of extra-...
journal_title:Current pharmaceutical design
pub_type: 杂志文章
doi:10.2174/138161212799040493
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND & AIMS:Nowadays, the world is facing a common problem that the population aging process is accelerating. How to delay metabolic disorders in middle-aged and elderly people, has become a hot scientific and social issue worthy of attention. The liver plays an important role in lipid metabolism, and abnormal li...
journal_title:Current pharmaceutical design
pub_type: 杂志文章
doi:10.2174/1381612826666200605111232
更新日期:2020-01-01 00:00:00
abstract::Psoriasis is an immune-mediated, chronic and recurrent inflammatory skin disease, prevalent worldwide, and represents an important burden in life quality of patients. The most common clinical variant is termed as psoriasis vulgaris or plaque psoriasis, which with an individualized and carefully monitored therapy can d...
journal_title:Current pharmaceutical design
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abstract::Alzheimer's disease (AD) is a chronic neurodegenerative disorder that is marked by cognitive dysfunctions and existence of neuropathological hallmarks such as amyloid plaques, and neurofibrillary tangles. It has been observed that a persistent immune response in the brain has appeared as another neuropathological hall...
journal_title:Current pharmaceutical design
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更新日期:2020-05-31 00:00:00
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journal_title:Current pharmaceutical design
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doi:10.2174/1381612826666200917145228
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更新日期:2004-01-01 00:00:00
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journal_title:Current pharmaceutical design
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更新日期:2012-01-01 00:00:00
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journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
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更新日期:2016-01-01 00:00:00
abstract::The involvement of the central nervous system (CNS) is one of the major causes of morbidity and mortality in systemic lupus erythematosus (SLE) patients and the less understood aspect of the disease. Its recognition and treatment continue to represent a major diagnostic and therapeutic challenge. Due to the lack of co...
journal_title:Current pharmaceutical design
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更新日期:2008-01-01 00:00:00
abstract::DARPins (designed ankyrin repeat proteins), new kinds of binding proteins, have the potential to overcome the defects of monoclonal antibodies, and hence may become the alternatives to antibodies and generate a novel therapeutic approach. DARPins can be selected to bind any given target proteins with high affinity and...
journal_title:Current pharmaceutical design
pub_type: 杂志文章,评审
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更新日期:2013-01-01 00:00:00
abstract::Although acute renal graft rejection rate has declined in the last years, and because an adequate therapy can improve graft outcome, its therapy remains as one of the most significant challenges for pharmacists and physicians taking care of transplant patients. Due to the lack of evidence highlighted by the available ...
journal_title:Current pharmaceutical design
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更新日期:2020-01-01 00:00:00
abstract::Ischaemic stroke of the brain accounts for about one third of all deaths in industrialized countries. Many of the patients who survive are severily impaired. Thus, there is an enormous need for pharmacotherapy for the treatment of ischaemic stroke. Why is such a treatment not available yet? Are the pathophysiological ...
journal_title:Current pharmaceutical design
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更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:Heat shock proteins are powerful endogenous cytoprotective proteins which help cells to survive recurrent cellular stress events. Identifying the underlying molecular mechanisms and molecular targets is especially interesting since it may help to develop new therapeutic strategies for the treatment of diseas...
journal_title:Current pharmaceutical design
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更新日期:2016-01-01 00:00:00
abstract::Immunotoxins (ITs) are protein-based drugs combining a target-specific binding domain (usually derived from an antibody) and a cytotoxic domain to kill target cells. They are among the most promising new therapeutic tools to fight cancer, and several clinical trials have been completed with encouraging results. Althou...
journal_title:Current pharmaceutical design
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更新日期:2009-01-01 00:00:00