scholarly journals Post-Marketing Surveillance of Fixed Dose Combination of Methylcobalamin, Alpha Lipoic Acid, Folic Acid, Biotin, Benfotiamine & Vitamin B6-Nutripathy for the Management of Peripheral Neuropathy

2014 ◽  
Vol 04 (02) ◽  
pp. 124-132 ◽  
Author(s):  
Manish Maladkar ◽  
Chitra Tekchandani ◽  
Urja Dave
Keyword(s):  
Folic Acid ◽  
Peripheral Neuropathy ◽  
Lipoic Acid ◽  
Vitamin B6 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Alpha Lipoic Acid ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Dose Combination

Post Marketing Surveillance Study to evaluate the Efficacy and Safety for the Combination of Alpha Lipoic Acid, Gingko Biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methylcobalamin, Vitamin E and Chromium Picolinate in the Patients of Tinnitus

2021 ◽  
Vol 6 (07) ◽  
pp. 435-440
Author(s):  
Dr. Mayuresh Kiran ◽  
Mr. Lalit Pawaskar ◽  
Ms. Pramita Waghambare ◽  
Ms. Shaheen Sheikh
Keyword(s):  
Vitamin E ◽  
Vitamin C ◽  
Lipoic Acid ◽  
Vitamin B6 ◽  
Fixed Dose ◽  
Chromium Picolinate ◽  
Alpha Lipoic Acid ◽  
Efficacy And Safety ◽  
Gingko Biloba ◽  
Post Marketing Surveillance

Introduction: Tinnitus is the false perception of sound. Normally it is considered to be developed due to oxidative stress to the inner ear. This study was conducted to test the efficacy and safety for the combination of Alpha lipoic acid, Gingko biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methylcobalamin, Vitamin E and Chromium Picolinate in the patients of tinnitus. Method: The study was conducted on 165 patients out of which 142 completed the study. Efficacy was evaluated by tinnitus symptom score (TSS). Patients were asked to rate the TSS ranging from 0 to 10 where 0 means no symptom and 10 means maximum tolerable symptoms. Safety assessment was made by analysing the adverse events reported by the patient. Efficacy and safety evaluation was done on day 0, 10 and 22. Results: Patients had TSS 6.26 on baseline visit which was reduced to 4.50 at day 10 and was further reduced to 2.47 at day 22. Also, in the clinical trial duration of 22 days, only 5 episodes of the adverse drug reactions were reported by the patient and all of them were of non-serious in nature and mild in intensity. Conclusion: The fixed dose combination of Alpha lipoic acid 200 mg, Gingko biloba 120 mg, Vitamin C 30 mg, Zinc 12 mg, Magnesium 10 mg, Vitamin B6 3 mg, Methylcobalamin 1500 mcg, Vitamin E 10 IU and Chromium Picolinate 1.66 mg equivalent to elemental chromium 200 mcg was found to be efficacious and safe for the treatment of Tinnitus.

scholarly journals POST-MARKETING SURVEILLANCE STUDY TO SUBSTANTIATE THE EFFICACY AND SAFETY FOR THE COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND CHLORPHENIRAMINE MALEATE IN INDIAN PATIENTS OF COMMON COLD

2021 ◽  
Vol 5 (7) ◽  
Author(s):  
Mayuresh Kiran ◽  
Lalit Pawaskar ◽  
Shaheen Sheikh ◽  
Pramita Waghambare
Keyword(s):  
Common Cold ◽  
Symptomatic Treatment ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Chlorpheniramine Maleate ◽  
Phenylephrine Hydrochloride ◽  
Indian Patients ◽  
Post Marketing Surveillance ◽  
Dose Combination

Introduction: Common cold is frequently occurring medical condition in developing countries like India. Common cold is self-limiting in nature so symptomatic treatment is always suggested. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold. Methodology: Total 180 patients were enrolled out of which 159 completed the study. Efficacy assessment was done by decrease in total symptom score (TSS) of common cold at day 3 and 5 as compared to the baseline (day 1). Safety assessment was made by analyzing the reported adverse events through the study. Results: Mean TSS at baseline was 6.62 which was decreased to 3.55 at day 3 and was further decreased to 0.68 at day 5. Majority of patients had complete relief from the symptoms of common cold and nearly all the patients had >50 % reduction in TSS. Also no unexpected or serious adverse event was found to be reported in the study duration of 5 days. Conclusion:  Fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet was found to be efficacious and safe for the symptomatic treatment of common cold in Indian patients. Keywords: Common cold, Paracetamol, Chlorpheniramine Maleate and Phenylephrine

scholarly journals Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia

2018 ◽  
Vol 9 (1) ◽  
pp. 32-40 ◽  
Author(s):  
Manfaluthy Hakim ◽  
Nani Kurniani ◽  
Rizaldy Taslim Pinzon ◽  
Dodik Tugasworo ◽  
Mudjiani Basuki ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Neuropathy ◽  
Vitamin B1 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Dose Combination

Background: Peripheral neuropathy is a common condition which can have a significant impact on quality of life. It occurs as a component of several common and rare diseases or can be idiopathic and can present with various symptoms.Aims and Objectives: This study is aimed at evaluating the effectiveness and safety of the fixed dose combination of vitamin B1, B6 and B12in mild to moderate peripheral neuropathy of various etiologies in the Indonesian population.Materials and Methods: This was a prospective, open label, multi-center, single arm observational study (Indonesian Clinical Trial Registry No: INA-KPA0DYA). A total of 411 subjects with mild to moderate peripheral neuropathy of various etiologies, who met the eligibility criteria, were included in the study. A subject was considered to have “completed” the study if the study procedures, up to Visit 3 (one month of treatment) were accomplished. Procedural results and 12-week clinical outcomes are reported.Results: Treatment with combination of vitamin B1, B6 and B12 in subjects with symptoms of PN showed significant improvement in overall Total Symptom Score (TSS), within 14 days. The treatment also successfully reduced individual components of TSS from baseline to Visit 5. A significant percentage reduction was also observed for all the Visual Analogue Scale (VAS) parameters at the end of 12 weeks, while the Quality of Life (QoL) scores increased from baseline to the end of treatment.Conclusions: The fixed dose combination of vitamin B1, B6 and B12 was effective and welltolerated in subjects with mild to moderate peripheral neuropathy, of various etiologies.Asian Journal of Medical Sciences Vol.9(1) 2018 32-40

scholarly journals Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 400
Author(s):  
Mario-Livio Jeličić ◽  
Edvin Brusač ◽  
Stanislav Kurajica ◽  
Matija Cvetnić ◽  
Daniela Amidžić Amidžić Klarić ◽  
...  
Keyword(s):  
Folic Acid ◽  
Principal Component ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Forced Degradation ◽  
Chemical Compatibility ◽  
Dose Combination ◽  
Multiple Drugs ◽  
Analytical Tools ◽  
Insight Into

The simultaneous administration of sulfasalazine and folic acid is regular practice in the therapy of inflammatory bowel diseases in order to maintain sufficient folate concentration in patients. Having multiple drugs in the therapy increases the possibility of patients failing adherence, thus unintentionally endangering their health. A fixed-dose combination of sulfasalazine and folic would simplify the classical polytherapeutic approach; however, the physicochemical compatibility investigation of two active pharmaceutical ingredients plays an important role in the development of such a product. In this work, various analytical tools were used to determine the physicochemical compatibility of sulfasalazine and folic acid. For the evaluation of chemical compatibility, infrared spectroscopy in combination with advanced statistical methods, such as the principal component analysis and cluster analysis, were used, whilst a simultaneous thermogravimetry/differential thermal analysis gave us an insight into the physical compatibility of two drugs. Isothermal stress testing, forced degradation and dissolution studies, followed by the analysis with a developed chromatographic method for the monitoring of folic acid, sulfasalazine and two of its related impurities, sulfapyridine and salicylic acid, gave us an insight into its chemical compatibility. The combination of the results obtained from the used techniques implies a satisfactory physicochemical compatibility between sulfasalazine and folic acid, which opens the path to the development of the proposed fixed-dose combination.

Development of a HPLC-DAD stability-indicating method and compatibility study of azathioprine and folic acid as a prerequisite for a monolayer fixed-dose combination

2021 ◽  
Vol 13 (11) ◽  
pp. 1422-1431
Author(s):  
Edvin Brusač ◽  
Mario-Livio Jeličić ◽  
Daniela Amidžić Klarić ◽  
Biljana Nigović ◽  
Sabina Keser ◽  
...  
Keyword(s):  
Folic Acid ◽  
Process Control ◽  
Quality Assessment ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Compatibility Study ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Dose Combination ◽  
Active Substances

Physicochemical compatibility of active substances confirmed using multiple techniques and a stability-indicating method developed for quality assessment and in-process control.

scholarly journals A Comprehensive Approach to Compatibility Testing Using Chromatographic, Thermal and Spectroscopic Techniques: Evaluation of Potential for a Monolayer Fixed-Dose Combination of 6-Mercaptopurine and Folic Acid

2021 ◽  
Vol 14 (3) ◽  
pp. 274
Author(s):  
Edvin Brusač ◽  
Mario-Livio Jeličić ◽  
Matija Cvetnić ◽  
Daniela Amidžić Klarić ◽  
Biljana Nigović ◽  
...  
Keyword(s):  
Folic Acid ◽  
Development Strategy ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Forced Degradation ◽  
Spectroscopic Techniques ◽  
Scanning Calorimetry ◽  
Forced Degradation Studies ◽  
Dose Combination ◽  
Inflammatory Bowel

In this work, a systematical compatibility investigation of 6-mercaptopurine and folic acid, two commonly used medications in the treatment of inflammatory bowel disease, for the needs of a fixed-dose combination development strategy is shown. Various techniques and approaches, such as differential scanning calorimetry, isothermal stress testing, attenuated total reflectance–Fourier-transform infrared spectroscopy, dissolution medium stability and forced degradation studies, were used to elucidate the possible interactions from different aspects. The results predominantly point to the absence of physicochemical interactions between the examined substances in a variety of possible conditions. However, the forced degradation of the blend of substances and excipients in basic conditions showed a drastic degradation of 6-mercaptopurine, signifying that attention needs to be directed to the careful selection of the excipients for the formulation. To sum up, our findings indicate that a fixed-dose combination of 6-mercaptopurine and folic acid could be produced using one formulation blend, immensely simplifying its manufacture.

Efficacy and safety of aclidinium/formoterol fixed-dose combination in patients with COPD, stratified by ICS use

Pneumologie ◽  
2016 ◽  
Vol 70 (S 01) ◽  
Author(s):  
ED Bateman ◽  
K Chapman ◽  
S Rennard ◽  
L Rekeda ◽  
M Moya ◽  
...  
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Dose Combination
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