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PubMed2005

Therapeutic strategies for tissue regeneration.

Tissue regeneration represents an emerging approach to the development of new medicines. It has even been described as the major therapeutic approach of the 21st century. Realization of this promise depends on overcoming a number of significant challenges. In the Society for Medicines Research symposium, held on June 6, 2005, in London, United Kingdom, and organized by Prof. Ian Morris (Hull York Medical School, York, UK) and Dr. Alan M. Palmer (Pharmidex, London, UK), several visionaries shared their confidence and determination to overcome these challenges. It is clear that persistence in this difficult area of research is increasingly paying dividends as the commercial potential of strategies for tissue regeneration are recognized by the biopharmaceutical industry, investors and government funding agencies worldwide.

Animals↗

PubMed2005

Pharmacokinetics of diclofenac sodium in normal man.

Diclofenac sodium was administered as 50 mg tablets to four healthy male volunteers in a two-way randomized crossover study in which volunteers were either fasted or were given a standard breakfast immediately prior to dosing. Blood samples were obtained upto 9 hours period and drug concentration were determined by HPLC method. Besides a significantly delayed (at p > 0.1) peak in fed state; an increase in absorption rate constant was observed as the only significant (at p > 0.05) effect of food on biopharmaceutic characteristic of diclofenac sodium. However, the intrinsic absorption of diclofenac sodium is also fast and it is not being the rate limiting factor in the bioavailability of diclofenac sodium, its decrease upto about 18 minutes (0.31 +/- 0.05 hr) from 11 minutes (0.19 +/- 0.02 hr) produces a null difference as the net effect on bioavailability, particularly when the drug is to be used in multiple dosage regimen.

Administration, Oral↗

PubMed2006

[Nanoparticles prepared with PLA derivatives].

Chemical modification of poly (DL-lactic acid) (PLA) is very important to give it various functionalities. When hydrophilic moieties are combined to PLA, the products tend to form the nanoparticles with the hydrophilic moieties as their shell and PLA as a core in aqueous medium. The nanoparticles produced with such PLA derivatives are also expected to exhibit various functions physicochemically and physiologically. Further, they can work well as a valuable depot of biologically active reagents. In this section, the preparative procedure of PLA derivaties and several nanoparticles prepared with PLA derivatives are introduced. Moreover, the physicochemical and biopharmaceutical characteristics of the nanoparticles are overviewed.

Chemical Phenomena↗

PubMed2006

Glycoscience -- a new frontier in rational drug design.

Glycans are the most abundant and most diverse biopolymers in nature. Because of their highly specific interactions with physiological receptors, they participate in many crucial biological processes. All these processes are potential targets for therapeutic intervention, and carbohydrate-based drugs are rapidly being taken up by the modern biotechnology and pharmaceutical industry. Recent developments in the field of glycobiology have overcome the problem of glycan analysis and synthesis; and many compounds based on carbohydrates are now in various stages of clinical trials. This article presents glycoproteins in a new light, as an important biopharmaceutical target, giving an overview of their potential use as therapeutic glycoproteins and proteoglycans, inflammation blockers, cancer therapeutics and vaccines, inhibitors of pathogenic microbes, viral inhibitors and potential aids in the treatment of lysosomal diseases, neurological diseases and transplantation rejection.

Animals↗

PubMed2006

Cryptic protein fragments as an emerging source of peptide drugs.

This commentary evaluates the newly proposed concept of crypteins - peptides with embedded cryptic activity - as a source of peptide drugs. Although several crypteins are undergoing advanced clinical trials, and one cryptein, adrenocorticotropic hormone (ACTH), is already widely used as a therapeutic, crypteins remain an underappreciated class of biopharmaceuticals. The systematic exploitation of crypteins provides a novel source of peptide drugs, and may also provide templates for developing peptidomimetic compounds. In addition, crypteins appear to offer several advantages over synthetic protein libraries and other protein scaffolds.

Animals↗

PubMed2006

Validation of a reversed-phase HPLC method for quantitative amino acid analysis.

A semi-automated method for amino acid derivatization and analysis has been validated for use in analysis of protein biopharmaceuticals. The method includes protein hydrolysis, o-phthalaldehyde derivatization, and reversed-phase high-performance liquid chromatography analysis in a general-purpose UV-visible high-performance liquid chromatography system. Amino-acid derivatization is performed automatically by the high-performance liquid chromatography autosampler right before injection. The required validation parameters, i.e., specificity, linearity, accuracy, precision, limit of detection, and limit of quantification, were studied for bovine serum albumin and for a recombinant human Fab fragment. The method can be employed as an absolute quantification method for determination of extinction coefficients of recombinant proteins.

Albumins↗

PubMed2006

[Pharmacokinetic model for the enterohepatic circulation of mycophenolic acid].

AIM: To develop a pharmacokinetic model for the enterohepatic circulation of mycophenolic acid (MPA). METHODS: Twenty healthy volunteers were orally given a single dose of 500 mg mycophenolate mofetil. Plasma samples were collected during 48 hours and MPA concentration was measured by HPLC method. Pharmacokinetic (PK) model was established based on physiological and biopharmaceutical consideration and PK parameters were obtained using nonlinear mixed effect model. RESULTS: The proposed model included an intestinal compartment and gall bladder compartment in addition to the central compartment. The predicted time-concentration curve and AUC0-t, Cmax, Tmax estimated by the established model were in agreement with the observations. CONCLUSION: The established model was well defined for the MPA disposition and could afford a useful approach for the further clinical investigation.

Adult↗

PubMed2006

[The use of mesenchymal stromal cells in oncology and cell therapy].

The unique properties of stem cells are opening the door for the development of new therapeutic approaches notably in oncology and regenerative medicine. Embryonic stem cells are theoretically very promising for that purpose. However, autologous stem cells derived from blood and bone marrow are the ones which have been tested in clinical trials. Amongst these, adult mesenchymal stromal cells (MSCs) possess particularly attracting properties, as they are easily expanded in vitro and possess the potential to differentiate into multiple cell lineages. Moreover, MSCs can be genetically modified and utilized as a biopharmaceutical. Several research groups are currently investigating both the fundamental properties of MSCs and applicable therapies derived from their use, particularly in cardiology but also in cancer and immunomodulation. Recently, we described that under appropriate stimulation, MSCs can behave as potent antigen-presenting cells (APCs) which is of interest in our understanding of hematopoietic system immunobiology. In addition, the antigen-presenting functions of MSC could theoretically be exploited as a new therapeutic tool in cancer therapy in order to amplify immune responses against tumor-specific antigens. In addition, genetically-modified MSCs are widely tested in preclinical studies and we will here present our results regarding IL2-producing MSCs as an anticancer agent. In Canada, the activities within the field of progenitor and stem cell therapeutics has been consolidated within the National Canadian Stem Cell Network which groups researchers, clinicians, engineers and ethicists, all dedicated to study this new promising pharmaceutical avenue.

Adult↗

PubMed2006

[Ester prodrug of scutellarin: synthesis, physicochemical property and degradation].

AIM: To establish the fundamentals for the design of scutellarin prodrug and formulation with feasible physicochemical and biopharmaceutical properties by esterifying scutellarin, an active component with poor absorption extracted from Erigeron breviscapus of Chinese medicine. METHODS: With the method of salifying followed by esterifying, ethyl and benzyl ester of scutellarin were synthesized. Glycolamide ester of scutellarin was also synthesized with an improved method. Their structures were confirmed by MS and 1H NMR. The solubility and partition coefficient of the prodrugs were determined and their degradations were investigated in various buffers and in human plasma. The emulsion and cyclodextrin complex of glycolamide ester were prepared and the protection of the ester from degradation was compared in the intestinal tract contents. Furthermore, the degradation of glycolamide ester in the homogenates of various intestinal segments was studied. Results Three prodrugs were synthesized successfully and their structures were confirmed. Glycolamide ester of scutellarin showed better stability in the aqueous solution (t(1/2) approximately =16 d, pH 4.2) and the shortest half-life in the human serum (t(1/2) approximately =7 min). Compared with scutellarin, the solubility of glycolamide ester was increased about ten times in pH 4.0 buffer, and about thirty five times in water. Partition coefficient of the glycolamide ester increased significantly from -2.56 to 1.48. However, the ester degradation in the homogenates of intestinal mucus would be an obstacle for its absorption. The degradation rates were in the order duodenum > ileum > or = jejunum > colon. The emulsion showed a better protection of glycolamide ester from the degradation than cyclodextrin complex. CONCLUSION: Glycolamide ester of scutellarin shows better physicochemical properties than ethyl and benzyl eater of scutellarin, but its stability in intestinal tract needs to be improved. The emulsion or / and colon-targeted delivery may be selected as one of strategies to decrease the presystemic degradation.

Animals↗

PubMed2001

Clinical genetics in pediatric physical therapy practice? The future.

PURPOSE: This article provides a review of the current state of incorporating genetic information into clinical practice and looks to the future, which is just around the corner. KEY POINTS: The explosion of genetic information spurred by the Human Genome Project has resulted in a literal revolution in the use of genetic information in a clinical practice setting. Currently, information from the Human Genome Project is being used in the area of genetic diagnostics, and in genetically engineered biopharmaceuticals. Although this information is only in the infancy of its development, its direct incorporation into clinical practice already has affected the day-to-day services provided by practically all health care specialties. SUMMARY: The rapid development of genetic information requires those in clinical practice to maintain their currency in genetic information so that they can refer patients to appropriate genetic professionals.

Journal Article↗

PubMedDate not supplied

Prodrugs and soft drugs.

This review focuses on a new approach to the development of drugs, namely on prodrugs and soft drugs. Nowadays, we try to design drugs that heal sick people having the best acceptance of patients. They must be efficient and selective on their site of action and must be metabolized to non-toxic derivatives. Both, prodrugs and soft drugs should have good distributive properties to enhance their quality. They are designed to maximize the amount of an active drug that reaches its target, through changing the physicochemical, biopharmaceutical or pharmacokinetic properties of drugs. Prodrugs are changed into the active drug within the body through enzymatic or non-enzymatic reactions. Soft drugs are novel and active analogues of already known therapeutic agents. It is expected that continued studies will improve drug properties so as to achieve the best drug delivery system.

Chemistry, Pharmaceutical↗

PubMedDate not supplied

Impact of tubing material on the failure of product-specific bubble points of sterilizing-grade filters.

The following study was conducted to determine the effect of different preservatives commonly used in the biopharmaceutical industry on the product-specific bubble point of sterilizing-grade filters when used to filter product processed with different types of tubing. The preservatives tested were 0.25% phenol, m-cresol, and benzyl alcohol. The tubing tested was Sani-Pure (platinum-cured silicone tubing), Versilic (peroxide-cured silicone tubing), C-Flex, Pharmed, and Cole-Parmer (BioPharm silicone tubing). The product-specific bubble point values of sterilizing grade filters were measured after the recirculation of product through the filter and tubing of different types of materials for a total contact time of 15 h. When silicone tubing was used, the post-recirculation product-specific bubble point was suppressed on average 13 psig when compared to the pre- recirculation product-specific bubble point. Suppression was also observed with C-Flex, but to a much lesser extent than with silicone tubing. Suppression was not observed with Pharmed or BioPharm tubing. Alcohol extractions performed on the filters that experienced suppressed bubble points followed by Fourier transform infrared spectroscopy analysis indicated the filters contained poly(dimethylsiloxane). Direct addition of poly(dimethlysiloxane) to solutions filtered through sterilizing-grade filters suppressed the filter bubble points when tested for integrity. Silicone oils most likely reduced the surface tension of the pores in the membrane, resulting in the ability of air (or nitrogen) to pass more freely through the membrane, causing suppressed bubble point test values. The results of these studies indicate that product-specific bubble point of a filter determined with only product may not reflect the true bubble point for preservative-containing products that are recirculated or contacted with certain tubing for 15 h or greater. In addition, tubing material placed in contact with products containing preservatives should be evaluated for impact to the product-specific bubble point when being utilized with sterilizing-grade filters.

Drug Industry↗

PubMed2006

Systems biology: Potential to improve decision making in pharmaceutical development.

On October 5, 2006, the New England Systems Biology Association held its first annual meeting at Bentley College, Waltham, Massachusetts. The meeting was organized under the title "Systems Biology in Drug Discovery" and was devoted to the presentation of current status and advances in this new and ever-expanding field in medical sciences. It brought together biologists, biochemists, physicians, physicists and engineers, as well as leaders in biopharmaceutical industry interested in this field of science and its possible impact on anticancer drug discovery. The meeting consisted of two sessions, one in the morning and one in the afternoon and a panel discussion at noon. Each session hosted four speakers and a panel discussion featuring five discussants. Each session also included keynote speakers. Systems biology can help to identify disease-specific molecules and drug-specific targets. This is especially useful as a new tool in diagnostic approaches and drug discovery. Using specific techniques like gene profiling, marker detection and kinase-specific substrate definition, and combining them with large databases and computational methods it is possible to look at the organism as a complex association of gene activation and control networks, and their products, and thus gain better and more realistic insights into disease processes and into drug mechanisms.

Antineoplastic Agents↗

PubMedDate not supplied

Boundary and airlock design issues in aseptic facilities.

As more potentially hazardous biopharmaceutical and powder derivative products are being processed aseptically, the term "containment" in aseptic facility design must take on a broader definition. Contamination control must address not only protection of the product, but the protection of aseptic facility workers and of the surrounding environment as well. This paper will focus on design issues related to the physical boundaries (walls, ceilings, doors, etc.) that separate aseptic areas from other spaces within a facility with particular emphasis on the design of airlocks as "control points" for contamination control.

Asepsis↗

PubMed1991

[Chronotherapy concept and the pharmacokinetic validation of a theophylline retard preparation for once-nightly administration (Euphylong)].

Many patients with asthma often experience a deterioration of symptoms at night and in the early morning resulting in sleep disruption and possibly impaired daily performance. A bronchodilator agent which exerts its maximal effect overnight to control nocturnal symptoms, without a worsening of the disease during the daytime, should improve the treatment of asthma. In the case of theophylline, it has been shown in asthmatic patients that a chronotherapeutically optimized formulation which provides the highest serum theophylline concentrations during the critical early morning hours resulted in better airflow levels overnight than the conventional twice daily regimen without loss of airflow in the afternoon. During clinical routine, this chronotherapeutically optimized drug delivery can only be ensured if there is no food interaction. In particular, dose dumping must be excluded. One absolute prerequisite for this is the pH-independent drug release in vitro. In addition to a "state-of-the-art" biopharmaceutic formulation, an easy-to-use guidance for individualizing the theophylline dose should be provided. This in turn is only possible if the concentration/time profiles show good reproducibility between subjects, from day to day, and for different dose levels. Finally, batch-to-batch bioequivalence has to be ensured. It is shown that Euphylong satisfies all of the above requirements.

Asthma↗

PubMed1991

Clinical applications of recombinant macrophage-colony stimulating factor (rhM-CSF).

rhM-CSF has diverse in vitro and in vivo hematologic and metabolic effects. Clinical trials with this new biopharmaceutical are now in progress and early results have confirmed preclinical findings. The major demonstrated effects of rhM-CSF include an increase in number and activation of monocytes and macrophages, the ability to enhance antibody-dependent cellular cytotoxicity, enhancement of macrophage microbial phagocytic and killing activity, cholesterol lowering, and platelet lowering. The range of potential indications for the use of rhM-CSF makes the further clinical development of this molecule both a challenge and an opportunity. Investigation of combination therapies with other cytokines or monoclonal antibodies will be an important aspect of future investigations.

Bone Marrow Transplantation↗

PubMed1991

Studies on dressings for dental surgery use. Part 1: Effect of plasticizers on gelatin gel etching rate.

For quantitative evaluation of the absorption rate of dental dressings made of gelatin, a biopharmaceutical model of etching of gelatin gels in vitro has been elaborated. For the optimum etching conditions of gelatin gel columns 900 BAEE units per ml trypsin solution was used at a temperature of 25 degrees C. It has been found, that addition of glycerol and propylene glycol insignificantly reduces the etching rate of gelatin gels, whereas the PEG 400, PEG 1500 and PVAL increase resistance of the gels against the etching action of trypsin. In the model provided well repeatable results the coefficient of variation of the average gel etching rate remained within the range of 0.45-0.57%.

Absorption↗

PubMedDate not supplied

[The bioavailability of nifedipine in different solid pharmaceutical preparations for oral use].

The paper reports on the bioavailability of niphedipine in various pharmaceutic preparations administered in a single dose of 10 mg, per os, to volunteer subjects: Niphedipine dragees (Terapia, Cluj-Napoca), Adalat capsules (Bayer); Adalat coated tablets (Bayer and Birlaşik Alman Ilac Fabricalari, Istanbul) and Corinfar dragées (VEB Arzneimittelwerk, Dresden). In the blood samples collected, niphedipine was determined by a gas-chromatographic procedure. Pharmacokinetic analysis of the experimental data was made by a digital computer. Bioavailability of niphedipine was the best with Adalat capsules. The relative bioavailability of the other products was: tablets (Adalat); 93%; dragées (Niphedipine): 92%; dragées (Corinfar 86%). Absorption speed of Niphedipine decreases in the order: capsules, tablets, indigenous and imported dragées. Statistical analysis (Student test) shows that the differences in bioavailability among the preparations are not important. Efficiently therapeutic plasmatic concentrations are maintained for about 6 hours after a single dose of 10 mg administered as tablets and dragées and for 8 hours in the case of capsules. Important differences exist between the maximum concentration of niphedipine in blood, following some differences in the absorption speed, achieved after administration of capsules, on the one hand, and of tablets and dragées on the other hand. Choosing the type of tablet depends, therefore, on the nature of the affection treated. Niphedipine (Terapia) has corresponding biopharmaceutic properties and is useful in treating hypertension and for preventing and treating anginal attacks.

Administration, Oral↗