Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000379
Sonalika Kushwaha
3D printing is one of the rapid prototyping technology, which produces 3D products using layer-by-layer process from digital designs. 3D printing has gained a lot of attention in pharmaceutical industries since FDA approved a 3D-printed SPRITAM® (levitracetam 1000 mg) fast dissolving tablets for the adjunct treatment of myoclonic seizures and primary generalized tonic-clonic seizures. There are various 3D printing methods employed for the drug product manufacturing which are used based on the materials, equipment, and solidification. Hot melt extrusion (HME) is one of the techniques which is used for 3D printing. This review article discusses the application of HME in 3D printing of pharmaceutical products. Uniting Hot melt extrusion (HME) for 3D printing with solid freeform fabrication (SFF) such as Fluid deposition method (FDM) offer great chances for designing a wide variety of drug delivery systems.
{"title":"Application of Hot Melt Extrusion in Pharmaceutical 3D Printing","authors":"Sonalika Kushwaha","doi":"10.4172/0975-0851.1000379","DOIUrl":"https://doi.org/10.4172/0975-0851.1000379","url":null,"abstract":"3D printing is one of the rapid prototyping technology, which produces 3D products using layer-by-layer process from digital designs. 3D printing has gained a lot of attention in pharmaceutical industries since FDA approved a 3D-printed SPRITAM® (levitracetam 1000 mg) fast dissolving tablets for the adjunct treatment of myoclonic seizures and primary generalized tonic-clonic seizures. There are various 3D printing methods employed for the drug product manufacturing which are used based on the materials, equipment, and solidification. Hot melt extrusion (HME) is one of the techniques which is used for 3D printing. This review article discusses the application of HME in 3D printing of pharmaceutical products. Uniting Hot melt extrusion (HME) for 3D printing with solid freeform fabrication (SFF) such as Fluid deposition method (FDM) offer great chances for designing a wide variety of drug delivery systems.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"10 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73011870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We completed a research study concerning degenerative disc disease (DDD) to prove the superiority of the Quadruple Blind-Study in accurately identifying the illness in patients against the Double Blind-Study. The protocol involved 160 male and female asymptotic patients with an average age of 37, living a normal lifestyle. The patients had no prior DDD diagnoses but only intermittent back pain. Our clinical findings showed 12% of patients positive for DDD. Using this same criterion, it was estimated that a Double Blind-Study would only make a 3% positive identification. This particular study gave our method a 300% greater efficacy in identifying DDD in the tested patients against the Double Blind-Study. Greater emphasis should be placed in utilizing this method in the United States Military. This would enable prompt identification of at risk soldiers, thus minimizing lost duty time and the loss of invaluable field and combat experience.
{"title":"Degenerative Disc Disease in the Active Military Special Forces and the Financial Benefits of Early Detection Using a Quadruple Blind-Study","authors":"Michael Burgio, Osita E Onyejekwe","doi":"10.4172/JBB.1000366","DOIUrl":"https://doi.org/10.4172/JBB.1000366","url":null,"abstract":"We completed a research study concerning degenerative disc disease (DDD) to prove the superiority of the Quadruple Blind-Study in accurately identifying the illness in patients against the Double Blind-Study. The protocol involved 160 male and female asymptotic patients with an average age of 37, living a normal lifestyle. The patients had no prior DDD diagnoses but only intermittent back pain. Our clinical findings showed 12% of patients positive for DDD. Using this same criterion, it was estimated that a Double Blind-Study would only make a 3% positive identification. This particular study gave our method a 300% greater efficacy in identifying DDD in the tested patients against the Double Blind-Study. Greater emphasis should be placed in utilizing this method in the United States Military. This would enable prompt identification of at risk soldiers, thus minimizing lost duty time and the loss of invaluable field and combat experience.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"142 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77797351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000376
E. Sevinsky, L. Silvestro†, A. Neatu, C. Roffé, S. Rizea‐Savu
A generic formula containing 14 mg of teriflunomide (Terflimida® test formulation) in oral coated tablets was compared to the reference product (Aubagio®) in a pharmacokinetic, open label, two-periods, two sequences, two-way crossover; block randomized single dose study in healthy male volunteers under fasting conditions.The statistical analysis of the pharmacokinetic data obtained in this study showed that the Teriflunomide formulations: Terflimida® coated tablets 14 (test formulation) and Aubagio® 14 mg coated tablets (reference formulation), were bioequivalent regarding the rate (Cmax) and the extent of absorption (AUC0-72), under fasting conditions. The Teriflunomide treatments (TEST and REFERENCE formulations), administered orally in single dose, to male healthy volunteers, under fasting conditions, were very well tolerated by all the participating subjects.
{"title":"Pharmacokinetic Bioequivalence Study of Two Formulations of Teriflunomide in Healthy Male Volunteers under Fasting Conditions","authors":"E. Sevinsky, L. Silvestro†, A. Neatu, C. Roffé, S. Rizea‐Savu","doi":"10.4172/0975-0851.1000376","DOIUrl":"https://doi.org/10.4172/0975-0851.1000376","url":null,"abstract":"A generic formula containing 14 mg of teriflunomide (Terflimida® test formulation) in oral coated tablets was compared to the reference product (Aubagio®) in a pharmacokinetic, open label, two-periods, two sequences, two-way crossover; block randomized single dose study in healthy male volunteers under fasting conditions.The statistical analysis of the pharmacokinetic data obtained in this study showed that the Teriflunomide formulations: Terflimida® coated tablets 14 (test formulation) and Aubagio® 14 mg coated tablets (reference formulation), were bioequivalent regarding the rate (Cmax) and the extent of absorption (AUC0-72), under fasting conditions. The Teriflunomide treatments (TEST and REFERENCE formulations), administered orally in single dose, to male healthy volunteers, under fasting conditions, were very well tolerated by all the participating subjects.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"24 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89779894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000e85
M. Butnariu
{"title":"Spice Plants and the Bioavailability of Nutrients","authors":"M. Butnariu","doi":"10.4172/0975-0851.1000e85","DOIUrl":"https://doi.org/10.4172/0975-0851.1000e85","url":null,"abstract":"","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"71 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87194796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hsiao-Hui Tsou, Chi Tian Chen, C. Hsiao, Yu-Chieh Cheng
Biosimilars have received much attention from sponsors and regulatory authorities while patents on many biological products had expired recently or will soon expire in the next few years. According to the definition of biosimilar product from the European Medicines Agency’s guidance and the U.S. Food and Drug Administration’s guidelines, biosimilar should be highly similar, not identical, to the innovative biological product. In this research, we focus on establishing posterior criterion to assess the biosimilarity between the biosimilar product and the innovator product. We consider the prior information of the reference product and a non-informative prior to build the mixture empirical prior information of the biosimilar product. We further construct a posterior criterion to check the biosimilarity between the reference product and the biosimilar product. If the posterior probability of the similarity criterion is higher or equal to a pre-specified level, the biosimilarity between the reference product and the biosimilar product will be concluded. The statistical properties of the proposed approach are discussed through numerical results in different scenarios. A real example is provided to illustrate applications of the proposed approach.
{"title":"Evaluation of Biosimilarity Based on an Empirical Bayes Method","authors":"Hsiao-Hui Tsou, Chi Tian Chen, C. Hsiao, Yu-Chieh Cheng","doi":"10.4172/jbb.1000367","DOIUrl":"https://doi.org/10.4172/jbb.1000367","url":null,"abstract":"Biosimilars have received much attention from sponsors and regulatory authorities while patents on many biological products had expired recently or will soon expire in the next few years. According to the definition of biosimilar product from the European Medicines Agency’s guidance and the U.S. Food and Drug Administration’s guidelines, biosimilar should be highly similar, not identical, to the innovative biological product. In this research, we focus on establishing posterior criterion to assess the biosimilarity between the biosimilar product and the innovator product. We consider the prior information of the reference product and a non-informative prior to build the mixture empirical prior information of the biosimilar product. We further construct a posterior criterion to check the biosimilarity between the reference product and the biosimilar product. If the posterior probability of the similarity criterion is higher or equal to a pre-specified level, the biosimilarity between the reference product and the biosimilar product will be concluded. The statistical properties of the proposed approach are discussed through numerical results in different scenarios. A real example is provided to illustrate applications of the proposed approach.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"21 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87011822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000375
Nahla Sameh, U. Aly, H. Abou-Taleb, Ahmed A. H. Abdellatif
Background: Wound healing is a normal biological complex and dynamic process of substituting injured and misplaced cellular structures and tissue layers. This complicated development is achieved through four different phases: haemostasis, inflammation, proliferation, and finally remodelling. These four phases must occur in the proper sequence and time frame to achieve successful wound healing. Over years topical antibiotics were applied on wounds but it causes side effects and resistance; that’s why it was a necessity to find a new topical wound healing drugs rather than antibiotics.Methods: Literature was searched in NCBI (The National Center for Biotechnology Information Advances Science and Health), Wiley online library, ScienceDirect database using the keywords Simvastatin, wound healing, Topical formulation. Articles that seemed suitable based on title and abstract were included. Also, a personal collection of literature on the subject pleiotropic effects of simvastatin, hydrogels, and polymeric nanoparticles was referred.Results: Beside cholesterol-lowering effect of Simvastatin (SIM), it has many unusual therapeutic modalities for different pathological disorders such as healing bone tissue, cancer cell inhibition, many inflammatory diseases and wound healing. SIM wound healing induction arises from its angiogenesis activity and antibacterial activity. It can interfere with bacterial protein synthesis and inhibits both multiple biosynthetic pathways and cellular processes in bacteria without the conventional antibiotics side effects or fear of bacterial resistance.Conclusion: This review discusses the wound types and wound healing process, the nanosizing advantage in wound healing, gels and hydrogel characters and the approved application of simvastatin topically to wound healing via promotion of epithelialization and antibacterial activity.
{"title":"Prospective Role of Simvastatin on Wound Healing: Review of the Literature","authors":"Nahla Sameh, U. Aly, H. Abou-Taleb, Ahmed A. H. Abdellatif","doi":"10.4172/0975-0851.1000375","DOIUrl":"https://doi.org/10.4172/0975-0851.1000375","url":null,"abstract":"Background: Wound healing is a normal biological complex and dynamic process of substituting injured and misplaced cellular structures and tissue layers. This complicated development is achieved through four different phases: haemostasis, inflammation, proliferation, and finally remodelling. These four phases must occur in the proper sequence and time frame to achieve successful wound healing. Over years topical antibiotics were applied on wounds but it causes side effects and resistance; that’s why it was a necessity to find a new topical wound healing drugs rather than antibiotics.Methods: Literature was searched in NCBI (The National Center for Biotechnology Information Advances Science and Health), Wiley online library, ScienceDirect database using the keywords Simvastatin, wound healing, Topical formulation. Articles that seemed suitable based on title and abstract were included. Also, a personal collection of literature on the subject pleiotropic effects of simvastatin, hydrogels, and polymeric nanoparticles was referred.Results: Beside cholesterol-lowering effect of Simvastatin (SIM), it has many unusual therapeutic modalities for different pathological disorders such as healing bone tissue, cancer cell inhibition, many inflammatory diseases and wound healing. SIM wound healing induction arises from its angiogenesis activity and antibacterial activity. It can interfere with bacterial protein synthesis and inhibits both multiple biosynthetic pathways and cellular processes in bacteria without the conventional antibiotics side effects or fear of bacterial resistance.Conclusion: This review discusses the wound types and wound healing process, the nanosizing advantage in wound healing, gels and hydrogel characters and the approved application of simvastatin topically to wound healing via promotion of epithelialization and antibacterial activity.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"89 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82223729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000383
P. Aitken, I. Salem, I. Stanescu, Rebecca Playne, H. Atkinson
The use of fixed-dose combination pain relief has the potential to enhance analgesic efficacy. The pharmacokinetic properties of oral medication can be altered by many factors, including food, concomitant medications, and drug formulation. During the present study the pharmacokinetic parameters of an acetaminophen and ibuprofen combination was tested in four formulations. Testing was performed in two clinical trials examining either fasting or fed dosing conditions in healthy male participants. Both trials were single center, open-label, randomized, single dose studies with a four-way crossover design to compare an oral suspension product, a sachet product, and two different tablet formulations (FDC500/150 and FDC325/97.5). Each dose contained acetaminophen 975-1000 mg and ibuprofen 292.5-300 mg. A total of 26 participants completed the fasting study, while 28 completed the fed study. The absorption limits of different formulations of acetaminophen and ibuprofen were within the 80-125% bioequivalence range in both fasting and fed conditions as measured by the area under the plasma concentration– time curve from time zero to the time of the last measurable plasma concentration (AUC(0-t)) and the area under the curve from time zero to infinity (AUC(0-∞)). The maximum measured plasma concentration (Cmax) for the two tablet formulations were bioequivalent in fed conditions for both acetaminophen and ibuprofen, while in fasting conditions ibuprofen was also bioequivalent. Food reduced the Cmax and increased the time at which maximum measured plasma concentration occurred (tmax) of both acetaminophen and ibuprofen. This effect was largest in the sachet and oral suspension formulations, likely due to the drug being dissolved prior to administration, conferring more rapid absorption from the gastrointestinal tract. All treatments were well tolerated, with no treatment-emergent adverse events occurring. Overall, differing formulations and fasting conditions can alter the pharmacokinetic parameters Cmax, AUC(0-t), AUC(0-∞) and tmax of acetaminophen and ibuprofen combinations although the overall absorption remains bioequivalent.
{"title":"A Single Dose, Four-Way, Open-Label Bioavailability Study of Oral Acetaminophen and Ibuprofen Combinations (Maxigesicandreg;) under both Fasting and Fed Conditions","authors":"P. Aitken, I. Salem, I. Stanescu, Rebecca Playne, H. Atkinson","doi":"10.4172/0975-0851.1000383","DOIUrl":"https://doi.org/10.4172/0975-0851.1000383","url":null,"abstract":"The use of fixed-dose combination pain relief has the potential to enhance analgesic efficacy. The pharmacokinetic properties of oral medication can be altered by many factors, including food, concomitant medications, and drug formulation. During the present study the pharmacokinetic parameters of an acetaminophen and ibuprofen combination was tested in four formulations. Testing was performed in two clinical trials examining either fasting or fed dosing conditions in healthy male participants. Both trials were single center, open-label, randomized, single dose studies with a four-way crossover design to compare an oral suspension product, a sachet product, and two different tablet formulations (FDC500/150 and FDC325/97.5). Each dose contained acetaminophen 975-1000 mg and ibuprofen 292.5-300 mg. A total of 26 participants completed the fasting study, while 28 completed the fed study. The absorption limits of different formulations of acetaminophen and ibuprofen were within the 80-125% bioequivalence range in both fasting and fed conditions as measured by the area under the plasma concentration– time curve from time zero to the time of the last measurable plasma concentration (AUC(0-t)) and the area under the curve from time zero to infinity (AUC(0-∞)). The maximum measured plasma concentration (Cmax) for the two tablet formulations were bioequivalent in fed conditions for both acetaminophen and ibuprofen, while in fasting conditions ibuprofen was also bioequivalent. Food reduced the Cmax and increased the time at which maximum measured plasma concentration occurred (tmax) of both acetaminophen and ibuprofen. This effect was largest in the sachet and oral suspension formulations, likely due to the drug being dissolved prior to administration, conferring more rapid absorption from the gastrointestinal tract. All treatments were well tolerated, with no treatment-emergent adverse events occurring. Overall, differing formulations and fasting conditions can alter the pharmacokinetic parameters Cmax, AUC(0-t), AUC(0-∞) and tmax of acetaminophen and ibuprofen combinations although the overall absorption remains bioequivalent.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"13 1","pages":"84-91"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74682883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The hypothesis for the design of this project was that the extended release formulation containing dimethyl fumarate 240 mg DIMEFUL®, developed by Gador will present similar bioavailability with respect to the reference formulation, TECFIDERA® by Biogen Idec, measured in terms of speed and absorption. A clinical study of single-dose bioequivalence (in 2 stages) was designed to be carried out in healthy subjects. This study was opened of two periods, two sequences, crossed, randomized under fasting conditions. Eight out of ten subjects involved in this pilot study (stage 1) were randomized and completed the 2 periods of administration of the treatments. Data of all the subjects who completed the 2 periods of treatment administration were used for pharmacokinetic purposes. The design of the study was adequate to determine the bioequivalence of the Test and Reference Products. The 7- day washout period was sufficient to allow the complete elimination of the formulations before the next dosing period. Conclusion: In relation to monomethyl fumarate; The extended release formulation containing dimethyl fumarate 240 mg, developed by Gador, DIMEFUL®, presents similar bioavailability, measured in terms of speed and extension of absorption in relation to the reference formulation, TECFIDERA® by Biogen Idec. Intrasubject CVs were on the order of 30% to 40% for the 3 pharmacokinetic parameters; indicating that the molecule and/or the formulation shows high variability in absorption and must be considered for the calculation of sample size of Stage 2. This improved process will serve for clinical assessment in patients. Individual plasma concentrations showed results lower than the lower limit of quantification of the validated analytical method. It is suggested to adjust the method by lowering said level for Stage 2. It is possible to consider extending the range of Bioequivalence for Cmax to 70-143% in Stage 2; since the intrasubject CV was >30% and the Reference geometric mean is between 0.80-1.25 in Stage 1.
{"title":"Bioequivalence of Two Oral Dimethyl Fumarate Extended Release Capsules in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study","authors":"Maligne Ge, Feleder Ec, Yerino Ga, Otero Am, Roldán Eja","doi":"10.4172/0975-0851.1000380","DOIUrl":"https://doi.org/10.4172/0975-0851.1000380","url":null,"abstract":"The hypothesis for the design of this project was that the extended release formulation containing dimethyl fumarate 240 mg DIMEFUL®, developed by Gador will present similar bioavailability with respect to the reference formulation, TECFIDERA® by Biogen Idec, measured in terms of speed and absorption. A clinical study of single-dose bioequivalence (in 2 stages) was designed to be carried out in healthy subjects. This study was opened of two periods, two sequences, crossed, randomized under fasting conditions. Eight out of ten subjects involved in this pilot study (stage 1) were randomized and completed the 2 periods of administration of the treatments. Data of all the subjects who completed the 2 periods of treatment administration were used for pharmacokinetic purposes. The design of the study was adequate to determine the bioequivalence of the Test and Reference Products. The 7- day washout period was sufficient to allow the complete elimination of the formulations before the next dosing period. Conclusion: In relation to monomethyl fumarate; The extended release formulation containing dimethyl fumarate 240 mg, developed by Gador, DIMEFUL®, presents similar bioavailability, measured in terms of speed and extension of absorption in relation to the reference formulation, TECFIDERA® by Biogen Idec. Intrasubject CVs were on the order of 30% to 40% for the 3 pharmacokinetic parameters; indicating that the molecule and/or the formulation shows high variability in absorption and must be considered for the calculation of sample size of Stage 2. This improved process will serve for clinical assessment in patients. Individual plasma concentrations showed results lower than the lower limit of quantification of the validated analytical method. It is suggested to adjust the method by lowering said level for Stage 2. It is possible to consider extending the range of Bioequivalence for Cmax to 70-143% in Stage 2; since the intrasubject CV was >30% and the Reference geometric mean is between 0.80-1.25 in Stage 1.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"61 1","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90219302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000e87
N. Srinivas
The availability of fixed dose combinations (FDC) continues to be on the rise since they provide convenience and compliance for the disease management [1,2]. Given the involvement of polypharmacy in the current disease management for certain chronic ailments, the development of newer FDC combinations to benefit patients in a disease area is amply justified [3,4]. A recent publication on this important topic lays out a strategy and framework for an unequivocal and unbiased evaluation of FDC product from a pharmacokinetic perspective [5]. Some key topics of discussion in this paper includes the attributes that contribute for the dose selection of the individual FDC drug components and the key features to determine the extent (or lack) of a pharmacokinetic drug-drug interaction between the two drugs in the FDC [5]. The intent of this editorial is to provide some perspectives on the altered changes in physiology in disease patients that may likely have an influence on the pharmacokinetic disposition of drugs that are used in the combination strategy.
{"title":"Drug Combination Strategy: Pharmacokinetics and Drug-Drug Interaction Considerations in Diseased Patients","authors":"N. Srinivas","doi":"10.4172/0975-0851.1000e87","DOIUrl":"https://doi.org/10.4172/0975-0851.1000e87","url":null,"abstract":"The availability of fixed dose combinations (FDC) continues to be on the rise since they provide convenience and compliance for the disease management [1,2]. Given the involvement of polypharmacy in the current disease management for certain chronic ailments, the development of newer FDC combinations to benefit patients in a disease area is amply justified [3,4]. A recent publication on this important topic lays out a strategy and framework for an unequivocal and unbiased evaluation of FDC product from a pharmacokinetic perspective [5]. Some key topics of discussion in this paper includes the attributes that contribute for the dose selection of the individual FDC drug components and the key features to determine the extent (or lack) of a pharmacokinetic drug-drug interaction between the two drugs in the FDC [5]. The intent of this editorial is to provide some perspectives on the altered changes in physiology in disease patients that may likely have an influence on the pharmacokinetic disposition of drugs that are used in the combination strategy.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"74 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76477978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-01-01DOI: 10.4172/0975-0851.1000384
Duna Sn, A. Ghita, S. Grasser, S. RizeaSavu
An innovative approach for the assessment of transdermal patches adherence to the skin was developed and applied post-hoc to supportive imaging data collected in an open label, two-period, two-sequence, two-way crossover, controlled, randomized, single dose study to assess adhesion performance of two buprenorphine formulations (generic versus originator), applied topically to healthy male and female volunteers. The technology used for data acquisition is called Medical Infrared Thermography (MIT), a non-invasive, non-radiating imaging technique for surface temperature mapping. The use of this technology in an adhesion performance study was based on the rationale that the surface of a transdermal patch reaches a temperature in equilibrium with that of the body area where it is applied and whenever a discontinuity between skin and patch exists, the transmission of thermic energy to the surface of the transdermal patch changes. In case air is interposed, the transmission is minimal so any cases of patch lift-off from skin become visible on thermograms. The thermograms were acquired in standardized conditions but were initially intended only as supportive imaging technique, while the primary adhesion performance data was acquired through the standard approach of visual examination coupled with manual markings. In this article we further demonstrate the value of the acquired thermograms as main adhesion assessment tools, used in conjuncture with an in-house validated image processing software for the actual quantification of percentages of detachment. This novel approach for automated and unbiased analysis of adhesion performance was shown to be highly reliable and reproducible, attributes that recommend it for future use as primary adhesion assessment tool pending completion of full method validation.
{"title":"Innovative Use of Medical Infrared Thermography to Evaluate Adhesive Properties of Two Buprenorphine Transdermal Patch Formulations in a Single Dose Adhesion Performance Study","authors":"Duna Sn, A. Ghita, S. Grasser, S. RizeaSavu","doi":"10.4172/0975-0851.1000384","DOIUrl":"https://doi.org/10.4172/0975-0851.1000384","url":null,"abstract":"An innovative approach for the assessment of transdermal patches adherence to the skin was developed and applied post-hoc to supportive imaging data collected in an open label, two-period, two-sequence, two-way crossover, controlled, randomized, single dose study to assess adhesion performance of two buprenorphine formulations (generic versus originator), applied topically to healthy male and female volunteers. The technology used for data acquisition is called Medical Infrared Thermography (MIT), a non-invasive, non-radiating imaging technique for surface temperature mapping. The use of this technology in an adhesion performance study was based on the rationale that the surface of a transdermal patch reaches a temperature in equilibrium with that of the body area where it is applied and whenever a discontinuity between skin and patch exists, the transmission of thermic energy to the surface of the transdermal patch changes. In case air is interposed, the transmission is minimal so any cases of patch lift-off from skin become visible on thermograms. The thermograms were acquired in standardized conditions but were initially intended only as supportive imaging technique, while the primary adhesion performance data was acquired through the standard approach of visual examination coupled with manual markings. In this article we further demonstrate the value of the acquired thermograms as main adhesion assessment tools, used in conjuncture with an in-house validated image processing software for the actual quantification of percentages of detachment. This novel approach for automated and unbiased analysis of adhesion performance was shown to be highly reliable and reproducible, attributes that recommend it for future use as primary adhesion assessment tool pending completion of full method validation.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"1 1","pages":"92-97"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89811686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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