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Expert Opinion on Pharmacotherapy Sep 2021: Testosterone deficiency (TD) is defined as low serum testosterone associated with symptoms and signs. There has been an increasing prevalence of TD in recent decades,... (Review)
Review
: Testosterone deficiency (TD) is defined as low serum testosterone associated with symptoms and signs. There has been an increasing prevalence of TD in recent decades, especially in males aged 15-39. Many of these men will require long-term testosterone therapy (TT). Although the end-goals for all treatments are essentially the same, strategies for increasing serum testosterone should be decided individually.: This review focuses on the pharmacological management of TD in adults which includes TT with different routes of administration, such as transdermal, buccal, intramuscular and subcutaneous injections, pellets, nasal gel, and oral (pills). The authors review the options for TT available in the USA with emphasis on newer therapies. Furthermore, they examine the efficacy of these therapies with comparison between potential advantages or disadvantages related to dosing, administration method, and adverse events.: Treating TD can be difficult due to the wide range of available medications, diverse side effects related to testosterone replacement and route-of-administration, and necessity for long-term therapy. The combination of pharmacological and non-pharmacological therapies can improve symptoms of TD and patient satisfaction. Each patient should be managed individually, and clinicians should consider available treatment regimens based on the route-of-administration, efficacy, safety, and cost based on a shared decision-making approach.
Topics: Administration, Cutaneous; Adult; Drug Implants; Hormone Replacement Therapy; Humans; Hypogonadism; Male; Testosterone; United States
PubMed: 33866902
DOI: 10.1080/14656566.2021.1918101 -
Current Opinion in HIV and AIDS Jan 2020Outline some regulatory considerations and scientific challenges related to the development of long-acting antiretrovirals (ARVs) for the treatment and prevention of... (Review)
Review
PURPOSE OF REVIEW
Outline some regulatory considerations and scientific challenges related to the development of long-acting antiretrovirals (ARVs) for the treatment and prevention of HIV-1 infection.
RECENT FINDINGS
Poor adherence to oral ARV regimens continues to pose challenges for effective treatment and prevention of HIV-1 infection. The development of long-acting ARV modalities for treatment and prevention of HIV-1 infection is emerging as a promising alternative to the current treatment and prevention paradigm and has gained considerable interest.
SUMMARY
The development of long-acting ARVs can present some unique drug development challenges. Advance planning and prioritization of studies early in development can facilitate the development of long-acting ARVs for the prevention and treatment of HIV-1 infection for all populations, including pediatric patients and pregnant women.
Topics: Adolescent; Anti-Retroviral Agents; Child; Delayed-Action Preparations; Drug Administration Routes; Drug Implants; Female; HIV Infections; HIV-1; Humans; Infusion Pumps, Implantable; Injections; Medication Adherence; Pregnancy
PubMed: 31483323
DOI: 10.1097/COH.0000000000000587 -
Scientific Reports Sep 2023Recently, Ta/Cu nanocomposites have been widely used in therapeutic medical devices due to their excellent bioactivity and biocompatibility, antimicrobial property, and...
Recently, Ta/Cu nanocomposites have been widely used in therapeutic medical devices due to their excellent bioactivity and biocompatibility, antimicrobial property, and outstanding corrosion and wear resistance. Since mechanical yielding and any other deformation in the patient's body during treatment are unacceptable in medicine, the characterization of the mechanical behavior of these nanomaterials is of great importance. We focus on the microstructural evolution of Ta/Cu nanocomposite samples under uniaxial tensile loading conditions at different strain rates using a series of molecular dynamics simulations and compare to the reference case of pure Ta. The results show that the increase in dislocation density at lower strain rates leads to the significant weakening of the mechanical properties. The strain rate-dependent plastic deformation mechanism of the samples can be divided into three main categories: phase transitions at the extreme strain rates, dislocation slip/twinning at lower strain rates for coarse-grained samples, and grain-boundary based activities for the finer-grained samples. Finally, we demonstrate that the load transfer from the Ta matrix to the Cu nanoparticles via the interfacial region can significantly affect the plastic deformation of the matrix in all nanocomposite samples. These results will prove useful for the design of therapeutic implants based on Ta/Cu nanocomposites.
Topics: Humans; Nanocomposites; Corrosion; Drug Implants; Edible Grain; Joint Dislocations
PubMed: 37737499
DOI: 10.1038/s41598-023-43126-6 -
Drug Development and Industrial Pharmacy Dec 2020The present study was designed to formulate and develop fast disintegrating pellets of poorly soluble model drug (cilostazol) by reducing the proportion of...
The present study was designed to formulate and develop fast disintegrating pellets of poorly soluble model drug (cilostazol) by reducing the proportion of micro-crystalline cellulose with pre-gelatinized starch (PGS), lactose and chitosan. The bioavailability enhancement of a model drug was achieved by preparing inclusion complex with Captisol® (Sulfobutyl Ether β cyclodextrin - SBE-β-CD). Extrusion-spheronization technique was used to formulate pellets. Placket-Burman design was used for the initial screening of most significant factors such as screen size (mm), ratio of micro crystalline cellulose: PGS + lactose + chitosan and % of HPMC which affects pellet properties. The inclusion complex of drug and Captisol (SBE-β-CD) was prepared by Solvent Evaporation method and were incorporated into pellets in a predefined proportion. Formulation was optimized by using 3 full factorial design, the optimized batch was selected on the basis of dependent variables such as % yield, pellet size, disintegration time and % Cumulative drug release (%CDR), the obtained results were 87.15%, 0.75 mm, 13 min and 91.024% respectively. Differential scanning calorimetry (DSC) and Fourier transform infrared spectrometry (FTIR) study revealed no significant interaction between drug and polymer. Scanning electron microscopy (SEM) confirmed uniform and spherical shaped pellets having pores on the surface which facilitates wicking action and fast disintegrating property of pellets. A design space was constructed to meet the desirable target and optimized batch. The scope of study can further extended to hydrophobic molecules which may useful due to rapid disintegration and enhanced dissolution rate.
Topics: Cellulose; Cilostazol; Drug Implants; Excipients
PubMed: 33026265
DOI: 10.1080/03639045.2020.1826509 -
Journal of Controlled Release :... May 2018
Topics: Drug Implants; Female; Humans; Inflammation; Lymphocyte Activation; T-Lymphocytes; Vagina
PubMed: 29678269
DOI: 10.1016/j.jconrel.2018.04.008 -
Journal of Ocular Pharmacology and... Sep 2016To survey the clinical responses to treatment of chronic postoperative and uveitic cystoid macular edema (CME) with a dexamethasone-based intravitreal implant...
PURPOSE
To survey the clinical responses to treatment of chronic postoperative and uveitic cystoid macular edema (CME) with a dexamethasone-based intravitreal implant (Ozurdex(®)).
METHODS
This retrospective, interventional case series reports on patients with chronic CME after uncomplicated vitrectomy for epiretinal gliosis or phacoemulsification (group 1: 12 eyes) or secondary to noninfectious endogenous uveitis (group 2: 36 eyes). Central retinal thickness (CRT), best-corrected visual acuity (BCVA, logMAR), and intraocular pressure (IOP) throughout follow-up were gleaned from the medical records.
RESULTS
In group 1, CRT decreased, compared with baseline, from 519 ± 43 to 297 ± 23 and 356 ± 49 μm by the 1- and 3-month visit (P = 0.02) and to 429 ± 57 μm before reimplantation. In group 2, CRT decreased from 460 ± 31 to 300 ± 21 and 312 ± 26 μm by the 1- and 3-month follow-up, respectively (P = 0.001), and to 373 ± 32 μm before reimplantation. Complete resolution of CME was achieved in 67% and 94% (groups 1 and 2, respectively) by 1 month and in 42% and 80% by 3 months after injection. In group 1, BCVA improved from 0.46 ± 0.08 to 0.27 ± 0.09 and 0.20 ± 0.06 (P = 0.01) by the 1- and 3-month follow-up, respectively, and to 0.32 ± 0.08 before reimplantation. In group 2, BCVA improved from 0.47 ± 0.06 to 0.34 ± 0.09, 0.26 ± 0.07, and 0.29 ± 0.08 (P < 0.05) at 1 and 3 months of follow-up and before reimplantation, respectively. A significant IOP increase was not observed in either group. Mean time to reimplantation of Ozurdex was 6.4 ± 5.7 and 6.6 ± 3.4 months for postoperative and uveitic CME, respectively.
CONCLUSION
Ozurdex seems to achieve a sustained effect over up to 6 months in postsurgical and uveitic CME.
Topics: Aged; Chronic Disease; Cohort Studies; Dexamethasone; Drug Implants; Humans; Intraocular Pressure; Intravitreal Injections; Kaplan-Meier Estimate; Macular Edema; Middle Aged; Retrospective Studies; Uveitis
PubMed: 27479780
DOI: 10.1089/jop.2016.0035 -
Women & Health Feb 2020The American College of Obstetricians and Gynecologists recommends long-acting reversible contraception (LARC) immediately postpartum for preventing unintended...
The American College of Obstetricians and Gynecologists recommends long-acting reversible contraception (LARC) immediately postpartum for preventing unintended pregnancy. This systematic review identified patients' and providers' knowledge, attitudes, and beliefs regarding immediate postpartum LARC use. Web of Science, Embase, PubMed, PsychInfo, and CINHAL databases (from inception to December 2018) were searched using LARC and immediate postpartum as search terms. The inclusion criteria were observational US studies, peer-reviewed, and English language, and the exclusion criterion was published abstracts only. The search yielded 4140 articles, and 18 articles were included in the final sample. Articles focused on women (n = 6) emphasizing patient preferences about the use of postpartum intrauterine devices (IUDs) and comprised samples of postpartum women. Among articles focused on providers (n = 12), knowledge regarding immediate postpartum LARCs varied. Providers reported lack of training and lack of comfort with regard to counseling and insertion as barriers to providing postpartum IUDs. This review identified literature regarding patient and provider perspectives on immediate postpartum LARC. Future work should ascertain patients' and providers' needs and preferences for integrating LARC counseling as a viable contraception option during the immediate postpartum period, ultimately promoting optimal inter-pregnancy intervals and overall health for women and future offspring.
Topics: Adult; Contraceptive Agents, Female; Counseling; Drug Implants; Female; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Intrauterine Devices; Long-Acting Reversible Contraception; Postpartum Period; United States
PubMed: 31122167
DOI: 10.1080/03630242.2019.1616042 -
Drug Delivery Dec 2021Minocycline hydrochloride (MINO) has been one of the most frequently used antibiotics in the treatment of periodontitis due to its antibacterial activity and...
Minocycline hydrochloride (MINO) has been one of the most frequently used antibiotics in the treatment of periodontitis due to its antibacterial activity and osteogenesis effects; however, high levels of MINO administered during the treatment halt the formation of new bone. Therefore, the purpose of the present study was to prepare a MINO-microsphere/sucrose acetate isobutyrate (SAIB) hybrid depot to reduce the burst release of MINO and ensure antibacterial and osteogenesis effects of MINO in the treatment of periodontitis. Uniform microspheres, approximately 5 µm size, with a slightly rough surface and different MINO loading (10, 12, and 14%) were prepared, and the microspheres were added into SAIB, after which the burst release significantly decreased from 66.18 to 2.92%, from 71.82 to 3.82%, and from 73.35 to 4.45%, respectively, and the release from all the MINO-microspheres/SAIB hybrid depots lasted for 77 days. In addition, cytotoxicity test showed that the MINO-microsphere with 12% drug loading promoted the proliferation of osteoblasts the most and was subsequently used in vivo experiments. Moreover, in the model of ligatured-induced periodontitis in SD rats, the MINO-microsphere/SAIB hybrid depot not only significantly increased the alveolar bone height and bone volume but also reduced the inflammation of the periodontal tissue. Additionally, it also inhibited the expression of the receptor activator of nuclear factor-kappa B ligand (RANKL) and promoted the expression of osteoprotegerin (OPG).. These results indicated that the MINO-microsphere/SAIB hybrid depot might be promising in the treatment of periodontitis.
Topics: Animals; Anti-Bacterial Agents; Chemistry, Pharmaceutical; Delayed-Action Preparations; Drug Implants; Drug Liberation; Microspheres; Minocycline; Osteoblasts; Osteogenesis; Osteoprotegerin; Periodontitis; Polylactic Acid-Polyglycolic Acid Copolymer; Rats; Rats, Sprague-Dawley; Receptor Activator of Nuclear Factor-kappa B; Sucrose
PubMed: 33779441
DOI: 10.1080/10717544.2021.1902020 -
Pharmaceutical Development and... Dec 2018The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic... (Review)
Review
The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated, and introduced in the market. The regulatory classification of any IDDS, as a 'drug', 'medical device' or a 'combination product', is the cornerstone in determining the regulatory pathway, which decides the quality control requirements preceding the marketing approval. IDDSs are generally recognized as combination products as they consist of two or more regulated components (drugs, medical devices or biological products) combined prior to use to function as a single entity. Although robust and defined US FDA regulatory pathways exist for each component independent of one another, the regulatory pathways for combination products are less formalized.
Topics: Animals; Drug Delivery Systems; Drug Evaluation, Preclinical; Drug Implants; Humans; Marketing of Health Services; Quality Control; United States; United States Food and Drug Administration
PubMed: 30084277
DOI: 10.1080/10837450.2018.1509348 -
AAPS PharmSciTech Jan 2020Our research group has pioneered the development of liquisolid pellets as a new drug delivery system targeting at the improvement of the dissolution rates of poorly...
Our research group has pioneered the development of liquisolid pellets as a new drug delivery system targeting at the improvement of the dissolution rates of poorly water-soluble drugs, combining the technological and biopharmaceutical advantages of both multiparticulate and liquisolid systems. Recently, Lam and collaborators claimed the invention of "liqui-pellets" as "the emerging next-generation oral dosage form which stems from liquisolid concept in combination with pelletization technology". However, the concept of liqui-pellet is not novel. As we demonstrate in this commentary, liqui-pellets are the same type of preparation as our previously and extensively reported liquisolid pellets. Liquisolid pellets have been disclosed in a patent application and public peer-reviewed articles covering the concept, preparation and challenges associated with these systems. There are no technical differences that justify excluding our previous reports as the first reports on liquisolid pellets or liqui-pellets. This commentary highlights the similarities between liquisolid pellets and liqui-pellets, focusing on the anteriority of liquisolid pellets as disclosed by our group.
Topics: Biopharmaceutics; Dosage Forms; Drug Compounding; Drug Delivery Systems; Drug Implants
PubMed: 31953566
DOI: 10.1208/s12249-019-1590-x