A Double-Blind, Randomized, Parallel Group, Placebo-controlled, Multicenter study to evaluate thebioequivalence (Clinical equivalence) of test formulation Azelaic acid 15% Gel of Kusum HealthcarePvt. Ltd., India with Skinoren 15 % Gel (Azelaic acid) Leo Pharma, EU among Subjects with mild tomoderate papular-pustular acne of the facial area or facial rosacea. - NIL

开始日期2023-08-30

申办/合作机构

Kusum Healthcare Pvt Ltd.

CTRI/2023/02/049970 / Recruiting临床4期

A Multicentric, Prospective, Observational, post Marketing surveillance study to evaluate safety of fixed dose combination of Vitamin C 1000mg + Zinc(in form of 32mg Zinc citrate trihydrate) 10mg effervescent tablet in clinical practice for treatment of Indian patients with vitamin C and zinc deficiency.

开始日期2023-02-27

申办/合作机构

Kusum Healthcare Pvt Ltd.

CTRI/2023/02/049361 / CompletedN/A

A Double-Blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Study to Evaluate the bioequivalence (Clinical equivalence) of test formulation benzocaine 206 mg rectal suppository of Kusum Healthcare Pvt Ltd., India With Relief® Advance (206 mg Benzocaine) rectal suppository; Istituto De Angeli S.r.l.; Località Prulli n.103/c-50066 Reggello (FI), Italy; among Subjects with anal fissures.

开始日期2023-02-06

申办/合作机构

Kusum Healthcare Pvt Ltd.

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2024-09-10·Reviews on Recent Clinical Trials

Multicentric Post-Marketing Surveillance (PMS) Observational Study of Ascorbic Acid and Zinc Effervescent Tablets in Indian Patients with Vitamin C and Zinc Deficiency

Article

作者: Sunena ; Swami, Ruchika

Aim:The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication.Methods:This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population.Results:Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The P-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions).Conclusion:The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.

2021-06-18·Nanoscience & Nanotechnology-Asia

Advancement in Nano Pharmaceutical Formulations and their Biomedical Use

作者: Malviya, Rishabha ; Bhardwaj, Vineet ; Özcengiz Gülay ; Ali Shahzad ; Voigt Birgit ; Becher Dörte ; Kurt-Kızıldoğan Aslıhan ; Aktaş Caner ; M. Naguib Abdelhady ; Sharma, Pramod K. ; Sharma, Akanksha ; Enumula Vinay ; Kumar, Dharmendra ; Neerati Prasad ; Ünsaldı Eser ; Özcan Servet

Nanoparticles and modified nanoparticles are used in biological and medical sciences as liposomes, polymeric micelles, block ionomer complexes, dendrimers, inorganic and organic nanoparticles. Nanoparticles and surface-modified nanoparticles show good stability and water solubility and can be used efficiently as drug delivery carriers. This paper summarizes the advancement in nanoparticles/surface-modified nanoparticles and patents based on them.

2019-03-20·Current Pharmaceutical Design4区 · 医学

3D Printing Technology in Design of Pharmaceutical Products

4区 · 医学

Review

作者: Abbas Bukhari, Syed Nasir ; Fazil, Mohammad ; Ahmed, Muhammad Masood ; Rizwanullah, Md. ; Amir, Mohd ; Ameeduzzafar ; Alruwaili, Nabil K.

Background: Three-dimensional printing (3DP) is a novel technology for fabrication of personalized medicine. As of late, FDA affirmed 3D printed tranquilize item in August 2015, which is characteristic of another section of Pharmaceutical assembling. 3DP incorporates a wide range of assembling procedures, which are altogether founded on computer-aided design (CAD), and controlled deposition of materials (layer-by-layer) to make freestyle geometries. Conventionally, many pharmaceutical processes like compressed tablet have been used from many years for the development of tablet with established regulatory pathways. But this simple process is outdated in terms of process competence and manufacturing flexibility (design space). 3DP is a new technology for the creation of plan, proving to be superior for complex products, customized items and items made on-request. It creates new opportunities for improving efficacy, safety, and convenience of medicines. Method: There are many of the 3D printing technology used for the development of personalized medicine on demand for better treatment like 3D powder direct printing technology, fused-filament 3D printing, 3D extrusion printer, piezoelectric inkjet printer, fused deposition 3D printing, 3D printer, ink-jet printer, micro-drop inkjet 3DP, thermal inkjet printer, multi-nozzle 3D printer, stereolithographic 3D printer. Result: This review highlights features how item and process comprehension can encourage the improvement of a control technique for various 3D printing strategies.Conclusion: It is concluded that the 3D printing technology is a novel potential for manufacturing of personalized dose medicines, due to better patient compliance which can be prepared when needed.

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