Journal of Drug Delivery and Therapeutics (JDDT)
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Effect of pH on Toxicity of Zinc Sulphate Hydrate Solutions Using the Spirotox Test
Introduction: Spirostomum ambiguum is commonly used as a biological indicator due to its high sensitivity to heavy metals. It functions normally across a wide pH range of 4.5 to 8.0. Testing on protozoan organisms provides a general understanding of the impact of pH on the toxicity of zinc in pharmaceuticals. By investigating the toxicity of zinc in environment with varying pH levels, the optimal environment for zinc absorption can be determined.
Objective: The objective of this study is to assess the toxicity of zinc sulphate solutions using different forms of hydrating and at various pH levels, applying the Spirotox method.
Methods: An experiment was conducted using a solution of pharmaceutical substances, specifically zinc sulphate heptahydrate and zinc sulphate monohydrate, with a concentration of 0.01 M. The study aimed to investigate the effect of the solution on the lifespan of S.ambiguum within the pH range of 4.8-6.5.
Results: Arrhenius activation energy (Ea linear correlates with LD50 oral toxicity for rats) decreases as pH increases from 4.8 to 6.5 for ⋅7 and ⋅ solutions. The values decrease from 140±10 kJ/mol to 55±10 kJ/mol and from 110±2 kJ/mol to 60±10 kJ/mol, respectively.
Conclusion: It was found that the toxicity of zinc sulphate hydrate solution towards S. ambiguum increased as the pH value increased. Hydrating of the active pharmaceutical substance was a crucial factor, it is critically important for preparation of solutions of an active pharmaceutical substance.
Keywords: zinc sulphate, Spirotox test, pH, activation energy, toxicity
The efficacy of using platelet-rich plasma (PRP) in the treatment of androgenic alopecia: a literature review
Androgenetic alopecia (AGA) is currently the primary cause of hair loss in both men and women. It is characterized by a progressive thinning of the hair follicles due to a shortening of the anagen phase of the hair growth cycle. The pathophysiology mainly involves the accumulation of dihydrotestosterone (DHT), a metabolite of testosterone, and a chronic perifollicular inflammatory process. The objective of this study is to evaluate, through a literature review, the validity, protocols, and efficacy of the use of platelet-rich plasma (PRP) in the treatment of patients with AGA. It is a review conducted in the first half of 2024, using the PubMed and BVS databases, employing Descritores em Ciência e Saúde (alopecia, plasma rico em plaquetas, terapia) and Medical Subject Headings (alopecia, platelet-rich plasma, therapy). Inclusion criteria consisted of: a) articles published between 2022 and 2024; b) written in Portuguese or English; c) full-text articles available for free; d) research focused on PRP therapy for the treatment of androgenetic alopecia in men. Twelve articles were included in the synthesis. Overall, the articles indicated that despite the need for standardized protocols, the use of PRP as a treatment for AGA shows promising results in the current context. The therapy demonstrated improvements in hair density and patient satisfaction, suggesting its potential as a viable option for managing androgenetic alopecia. Besides being a safe option with minimal side effects, its combination with other therapies, such as minoxidil, has brought beneficial outcomes for patients with this condition.
Keywords: Alopecia, Platelet-Rich Plasma, Therap
Herbs Used to Treat Depression: An Updated Review
Depression is a prevalent mental illness. In addition to being a substantial contribution to the overall global disease burden, depression is one of the main causes of disability worldwide. Complementary therapies are necessary because of the drawbacks of standard antidepressant therapy, including side effects, even though the former can help reduce depression symptoms and avoid relapse of the illness. Because they have fewer side effects and are less expensive than other therapies for depression, herbal medications have drawn a lot of interest recently. Compared to synthetic medications, herbal plants have fewer adverse effects and exhibit antidepressant properties. As such, they may be able to help people who are depressed. Because herbs have fewer adverse effects than conventional drugs, many people prefer them for symptom treatment. If traditional medications aren\u27t working for you because of side effects, poor efficacy, or accessibility issues, using phytomedicine can be a good alternative. This review will concentrate on herbs that are used to cure depression.
Keywords: Herbal medicines, Depression, Herb, Treatment, St. John’s Wor
Safūf-i Aslussūs: A time-tested polyherbal formulation for the management of Premature Ejaculation- A comprehensive review
Premature Ejaculation (PE) is the most prevalent male sexual complaint worldwide. The ability to control the timing of ejaculation is very important to get pleasure and to maintain the couple’s sexual health. PE is believed to have a multifactorial etiology which mainly includes psychogenic and biogenic factors. Currently available conventional drugs are based on mere assumptions and their use in PE is considered off-label as they have not been approved by the regulatory bodies. On the other hand, Unani System of Medicine has a holistic approach to the prevention and treatment of diseases and provides a line of treatment for PE which is mainly focused on the internal and external use of specific drugs for the restoration of lost powers, elimination of morbid humor and strengthening of organs, muscles, and nerves. In classical Unani literature, PE/Surʻat-i-Inzāl are described in detail under the heading of Amrāz-i-Bāh. In the series of drug therapy a polyherbal Unani formulation, Safūf-i Aslussūs mentioned in different Unani Pharmacopoeias for the management of PE, and Spermatorrhoea is widely prescribed and recommended for a long time by Unani physicians and it is a time-tested drug. This manuscript is an attempt to summarize scientific studies in support of the claim made by Unani physicians regarding Safūf-i Aslussūs.
Keywords: Safoof-i Aslussoos, Surʻat-i-Inzāl, Premature ejaculation, Unani System of Medicin
Evaluation of the analgesic and anti-inflammatory activities of Annona senegalensis Pers. (Annonaceae) leaves aqueous extract in rats and mice
Annona Senegalensis Pers. (Annonaceae) is a medicinal plant used to treat many pathologies, including inflammatory diseases and pain. The aim of this study was to investigate the analgesic and anti-inflammatory properties of Annona Senegalensis leaves aqueous extract in mice and rats. The analgesic activity was evaluated using the acetic acid (1%) induced writhing test and formalin (1%) test. The anti-inflammatory activity was performed using the carrageenan and the dextran induced hind paw oedema in rats.
The extract induced a significant (p<0.05) and dose-dependent decrease in abdominal contortions compared with control mice. The maximum inhibition was 63.36% at the dose of 200 mg/kg body weight. Only the late phase of formalin induced nociception was significantly inhibited by the extract with a maximum inhibition value of 56.96% at the dose of 200 mg/kg body weight. In the anti-inflammatory investigation, the aqueous extract of the leaves of Annona Senegalensis produced a significant (p<0.05) and dose-dependent decrease in edema induced by carrageenan and dextran. The maximum inhibition was 57.14% obtained at the fifth hour at the dose of 200mg/kg for the carrageenan test. For the dextran test, the maximum inhibition was 59.80% obtained at the second hour at the dose of 200 mg/kg body weight.
Our results show that Annona Senegalensis has peripheral analgesic and anti-inflammatory properties. It could therefore be an advantage in alternative medicine.
Keywords: Analgesic, Anti-inflammatory, Annona Senegalensis, Rats, Mic
Formulation and evaluation of bioadhesive buccal Films of Domperidone co-crystals by using Tamarind kernel powder as mucoadhesive polymer
As solubility plays key role in drug dissolution and bioavailability lots of techniques to enhance solubility are evolved. One of the techniques is co crystallization. The main aim of the work is to enhance the solubility of domperidone by co crystallization using coformers like Para amino benzoic acid and succinic acid. The cocrystals were evaluated for melting point and solubility enhancement. these cocrystals were used to prepare buccal films by solvent casting method. In the preparation of buccal films Tamarind kernel powder obtained from the seeds of Tamarind is used as mucoadhesive polymer and Hydroxy propyl methyl cellulose as film former, Polyethylene glycol 6000 as plasticizer, dehydrated banana powder as super disintegrant, sodium saccharin as sweetener and mixture of ethanol and water as solvents. The mucoadhesive strength of Tamarind kernel powder was determined using modified physical balance method. Four buccal films were prepared in which PDBF1 and PDBF2 are the two buccal films prepared using cocrystals of domperidone and Para amino benzoic acid and other two buccal films SDBF1 and SDBF2 with cocrystals of domperidone and Succinic acid. The buccal films were evaluated for different tests like folding endurance, swelling index and Surface pH. In vitro diffusion studies were conducted by Franz diffusion cell using egg membrane as semipermeable membrane and phosphate buffer of pH 7.4. The buccal films prepared with cocrystals of domperidone and succinic acid at weight ratio 1:2 has shown 86%drug release. The work has concluded that there is fold increase in aqueous solubility of Domperidone and the optimized formula is SDBF2 and Tamarind kernel powder can be used as mucoadhesive polymer in novel drug delivery systems.
Keywords: co crystals, solvent evaporation, muco adhesive, buccal films, solvent evaporatio
Glanzmann’s Thrombocytopenia: A Case Report
Glanzmann’s thrombocytopenia is a platelet disorder in which platelets have qualitative or quantitative deficiencies of the fibrinogen receptor α2bβ3. Most cases are hereditary but can be acquired also. This disorder in named after Dr.Eduard Glanzmann, who first described it in 1918. Its global prevalence is estimated to be one in a million with higher prevalence rate in population where consanguinity marriage is common. It has good prognosis with proper supportive care.
Case Summary: A 17-year male patient had come with complaint of severe epistaxis randomly for hours in a known case of Glanzmann’s thrombocytopenia which was diagnosed 10 years ago. With epistaxis he also had complaints of weakness in upper limbs and gastrocnemius muscle
Diagnosis: Glanzmann’s thrombocytopenia
Treatment: Inj. Etamsylate 500mg BD, Inj. Hemocoagulase 1IU OD, Inj. Tranexamic acid 500mg OD, Tab. Vitamin C BD, Tab. Calcium gluconate 500mg BD, Syp. Vitamin D3 and was transfused with PCV (A+) total 12 pint (200ml) and platelets 2 pint (200ml)
Keywords: Glanzmann’s thrombocytopenia, Epistaxis, Tranexamic acid, Congenital, Platelet Disorder
How AI Can Revolutionize the Pharmaceutical Industry
The pharmaceutical industry has seen a lot of transformation in the last five years because of technological innovations such as AI. AI-based technologies such as ML and DL are revolutionizing the sector and making processes such as drug discovery, research, dose optimization, therapeutic drug monitoring, drug repurposing, predictive analytics, and clinical trials much easier. Drug development is a complex, time consuming, and labor-intensive process. In some instances, drug development takes up to 10 years and a significant amount of investment. However, AI-based technologies are showing a lot of promise when it comes to simplifying the process and making it less-time consuming. The drug development involves a lot of data. AI-based technologies such as ML shows a lot of promise when it comes to analyzing and managing these large volumes of data making the process more manageable. AI has also simplified the process of identifying therapeutic targets. AI is also being used in drug design to help in making predictions of 3D structure of the target protein and predict drug-protein interactions. Other areas where AI is being used in drug discovery are de novo drug design, optimizing clinical trials, predictive modelling, and precision medicine. Despite the advantages that AI offers in pharma, it has its limitations. For instance, ethical considerations regarding patient data, privacy, and confidentiality remains a key issue. Risk of bias also raises ethical concerns that should be considered. Other limitations are limited skills that make it difficult to optimize AI, financial limitations that make it difficult to invest in AI, and data governance challenges.
Keywords: Artificial intelligence (AI), machine learning (ML), deep learning (DL), drug discovery, clinical trial
Psychologic Distress in Diabetic Patients
Diabetes mellitus presents a growing global health challenge, impacting millions and imposing significant burdens on individuals and healthcare systems alike. Diabetes distress encompasses the negative emotional impact of living with diabetes and holds significant clinical relevance, as it correlates with suboptimal self-care and glycemic control. This review explores the multifaceted relationship between diabetes and psychosocial factors, focusing on the concept of diabetes distress and its profound implications for patient well-being and disease management. As the prevalence of diabetes continues to rise, understanding and addressing the emotional toll of the condition becomes increasingly critical. Moreover, it explores the intricate dynamics of diabetes distress, self-care behaviors, and metabolic outcomes, emphasizing the importance of tailored interventions to alleviate distress and improve patient adherence and glycemic control. Greater diabetes distress correlates with detrimental medical and psychological outcomes, including suboptimal self-management behaviors such as reduced physical activity, unhealthy eating habits, medication non-adherence, and infrequent blood glucose monitoring. It\u27s associated with elevated A1C levels, increased risk of severe hypoglycemia, and diminished quality of life. Identification of diabetes distress is crucial, with validated screening tools available to aid clinicians in this process. Various management strategies are outlined, ranging from psychological interventions to effective patient-provider communication and supportive group interventions. By integrating psychosocial care into diabetes management, healthcare professionals can better address the holistic needs of patients, ultimately enhancing their quality of life and overall well-being.
Keywords: Diabetes mellitus, psychological distress, Diabetic distres
The MeViDa Study: Bioequivalence Study of FDC of Dapagliflozin, Vildagliptin SR and Metformin SR in Healthy Indian Volunteers: A Randomized, Open-Label, Crossover Study
Objective: To assess the pharmacokinetics and bioequivalence of Dapagliflozin 10mg + Vildagliptin Sustained Release (SR) 100mg + Metformin SR 1000mg fixed dose combination (FDC) tablets with DAPAMAC V 10 (Dapagliflozin 10mg + Vildagliptin SR 100mg tablets) and Glycomet 1g (Metformin SR 1000 mg tablets) in healthy adult male subjects under fasting conditions.
Material and Methods: This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study. Volunteers were randomized to receive either a test product or a reference product under the fasting condition with a seven-day washout period. The pharmacokinetics parameters evaluated were maximum plasma concentration (Cmax), the area under the curve (AUC) at time t (AUC0-t), and the total area under the curve (AUC0-∞). Adverse events were also assessed as safety endpoints.
Results: Twenty-four healthy adult male subjects were randomized, and 24 completed the study. The mean values for Cmax, AUC0-t, and AUC0-∞ were almost identical for test and reference products. The 90% confidence intervals of the ratios of adjusted geometric means for the pharmacokinetic parameters, i.e. Cmax, AUC0-t, and AUC0-∞ of the test product, were within the predefined bioequivalence limits of 80.00 to 125.00%. No adverse events or serious adverse events or deaths were reported during the study. All treatments were well tolerated.
Conclusion: The test formulation, Dapagliflozin 10mg + Vildagliptin SR 100mg + Metformin SR 1000mg FDC, were bioequivalent to DAPAMAC V 10 (Dapagliflozin 10mg + Vildagliptin SR 100mg tablets) and Glycomet 1g (Metformin 1000mg SR tablets) in healthy adult male subjects under fasting conditions.
Keywords: Bioequivalence, Fixed-Dose Combination, Dapagliflozin, Metformin, Sustained Release, Vildagliptin, AUC, Cma