scholarly journals A Review on process validation of solid dosage form

2021 ◽  
Vol 11 (4) ◽  
pp. 157-160
Author(s):  
Maulikkumar D Vaja ◽  
Bhoomi D Patel ◽  
Krina A Patel ◽  
Ankit B Chaudhary
Keyword(s):  
Compression Process ◽  
Concurrent Process ◽  
Validation Data ◽  
Granulation Process ◽  
Process Validation ◽  
Solid Dosage ◽  
Weight Variation ◽  
Stable Product ◽  
Tapped Density ◽  
Critical Process

Objective: The purpose of this work is to perform a study on concurrent validation of levonorgestrel tablet BP 0.03mg that will deliver process validation approach as a quality assurance means. The process validation program will be investigated so that the plan will be designed to the character of the procedure under study. This can be performed by checking and controlling the various critical in process parameters. Method: The samples from the three consecutive batches of levonorgestrel tablet 0.03mg are collected at the different stages of the manufacturing from dispensing, mixing, granulation process, drying process, blending process, compression process. Each and every parameter are analyzed and tested as per the specifications and all the data are recorded. The obtained results must be within the specified limit range. Result: The results obtained from the evaluation of different parameters like bulk density, tapped density, friability, hardness, weight variation, and assay were found to be within specification limit range. Conclusion:  The conclusion of the concurrent process validation of levonorgestrel tablet BP 0.03mg is based on the result of the validation data of three consecutive batches. It is concluded that the manufacturing process used for levonorgestrel consistently producing the stable product meeting it is predetermined specification and quality attributes. Keywords: Concurrent process validation, Process validation, Levonorgestrel, Critical process parameter. 

STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (10) ◽  
pp. 42-50
Author(s):  
Hemant S. Kandle ◽  
Sangram S. Patil ◽  
Sujata S. Sawant ◽  
Ganesh B. Vambhurkar ◽  
Asha M. Jagtap ◽  
...  
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Process Parameter ◽  
Regulatory Requirements ◽  
Validation Data ◽  
Process Validation ◽  
Critical Process Parameter ◽  
Quality Control Testing ◽  
Quality Product ◽  
High Degree ◽  
Critical Process

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assurance that the product meets the predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging its in house and compendial specification. Three initial process validations batches APL/008, APL/009 and APL/010 were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance so that manufacturing process produces a quality product.

scholarly journals Process validation of sucralfate oral suspension

2021 ◽  
Vol 12 (3) ◽  
pp. 2005-2013
Author(s):  
Aluri Nandini ◽  
Ravi G
Keyword(s):  
Manufacturing Process ◽  
Oral Suspension ◽  
Process Variables ◽  
High Quality ◽  
Validation Data ◽  
Process Validation ◽  
Critical Elements ◽  
Commercial Purpose ◽  
Critical Process

Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to demonstrate and standardize the data that should be routinely included in the marketing authorization dossier describing evolution and validation of the manufacturing process and distinguish from the validation data which more properly fall under the remit of GMP inspection. During the study of critical process variables of sucralfate oral suspension were validated to demonstrate consistency of manufacturing process to produce the produce the product of desired quality. The validation studies were conducted which were intended for the use of commercial purpose so this validation study is concurrent type. All the in-process variables and finished product characteristics were monitored; the statistical analysis of data was carried out. Further from the results, it is inferred that the manufacturing process of sucralfate oral suspension was validated.

scholarly journals FORMULATION AND EVALUATION OF FLURBIPROFEN FAST DISINTEGRATING TABLETS USING NATURAL SUPERDISINTEGRANTS

2016 ◽  
Vol 9 (6) ◽  
pp. 247 ◽  
Author(s):  
Mohammed Sarfaraz ◽  
Surendra Kumar Sharma
Keyword(s):  
Drug Release ◽  
Angle Of Repose ◽  
Lepidium Sativum ◽  
Disintegration Time ◽  
Natural Sources ◽  
Weight Variation ◽  
Wetting Time ◽  
Tapped Density ◽  
Fast Disintegrating Tablets

ABSTRACTObjective: The main objective of this research was to formulate Fast disintegrating tablets of Flurbiprofen incorporating superdisintegrants, isolated from natural sources like Plantago ovata (PO) seeds, Lepidium sativum (LS) seeds and agar-agar.Methods: Superdisintegrants were isolated from their natural sources using reported methods. Swelling index and hydration capacity was determined for the natural superdisintegrants to know their disintegration capacity. The tablet formulations were designed using isolated natural superdisintegrants. The powder blends were evaluated for pre-compressional parameters like angle of repose, bulk density, tapped density, carr’s index, and hausner’s ratio. Fast disintegrating tablets were prepared by direct compression method. The compressed tablets were characterized for post compression parameters.Results: All formulations had hardness, friability, weight variation and drug content within the pharmacopoeial limits. The wetting time was 84 to 254 sec, in vitro disintegration time was between 59.2 to 221 sec, and in-vitro drug release was as low as 11.80% (LS1) to a maximum of 98.99% (PO4) after 4 min of study. Among all, optimized formulation was PO4, as it showed good wetting time (84 sec), fastest disintegration time (59.2 sec), dispersion time (135 sec) and drug release of 98.99.% within 4 min.Conclusion: Flurbiprofen FDT’s were successfully developed using isolated natural disintegrants. The natural disintegrants isolated showed promising results and can prove as effective alternative for synthetic disintegrants.

scholarly journals Drying Technologies for the Stability and Bioavailability of Biopharmaceuticals

Pharmaceutics ◽  
2018 ◽  
Vol 10 (3) ◽  
pp. 131 ◽  
Author(s):  
Fakhrossadat Emami ◽  
Alireza Vatanara ◽  
Eun Park ◽  
Dong Na
Keyword(s):  
Freeze Drying ◽  
Therapeutic Proteins ◽  
Drying Methods ◽  
Solid Dosage Forms ◽  
Solid Dosage ◽  
Supercritical Fluid Drying ◽  
Protein Properties ◽  
Critical Process Parameters ◽  
The Stability ◽  
Critical Process

Solid dosage forms of biopharmaceuticals such as therapeutic proteins could provide enhanced bioavailability, improved storage stability, as well as expanded alternatives to parenteral administration. Although numerous drying methods have been used for preparing dried protein powders, choosing a suitable drying technique remains a challenge. In this review, the most frequent drying methods, such as freeze drying, spray drying, spray freeze drying, and supercritical fluid drying, for improving the stability and bioavailability of therapeutic proteins, are discussed. These technologies can prepare protein formulations for different applications as they produce particles with different sizes and morphologies. Proper drying methods are chosen, and the critical process parameters are optimized based on the proposed route of drug administration and the required pharmacokinetics. In an optimized drying procedure, the screening of formulations according to their protein properties is performed to prepare a stable protein formulation for various delivery systems, including pulmonary, nasal, and sustained-release applications.

scholarly journals Synthesis and Physicochemical Characterization of Banana Starch Tartrate and its Application as Disintegrant in Telmisartan Tablets

2020 ◽  
Vol 10 (3) ◽  
pp. 65-72
Author(s):  
Abhijeet Vishnu Puri ◽  
Prakash D. Khandagale ◽  
Ankita U. Tiwari ◽  
Rekhadevi H. Chaudhary ◽  
Sonam B. Kartan
Keyword(s):  
Physicochemical Characterization ◽  
Angle Of Repose ◽  
Compression Technique ◽  
Swelling Properties ◽  
Sodium Starch Glycolate ◽  
Weight Variation ◽  
Dispersible Tablet ◽  
Tapped Density ◽  
Clear Solution

The present investigation was aimed to isolate banana starch (BS), synthesis of banana starch tartrate (BST), characterization, and application as a novel disintegrant in telmisartan tablets. Starch tartrate was synthesized by the esterification process by the treatment of tartaric acid on the backbone of the BS. Synthesized BST was found to be fine, slightly free-flowing and crystalline powder. The synthesized BST was subjected to Scanning Electron Microscopy (SEM) and micrometric evaluation. Flow properties of BS and BST were determined as an angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio, etc. BST exhibited good swelling properties and showed no gelling at 100°C but it was transformed into a clear solution. Fourier transform infrared spectra (FTIR) did not show the presence of any significant interaction between BST and Telmisartan(T). The direct compression technique was employed in formulating telmisartan tablets using BST sodium starch glycolate and crospovidone as a disintegrant.  Tablets were comparatively evaluated for weight variation, thickness, hardness, friability, and disintegration. The tablets formulated using BS and BST passed prescribed evaluation tests for weight variation, friability, hardness, and thickness. The tablets formulated using BST as disintegrant gave optimum disintegration compared to those tablets containing sodium starch glycolate and crospovidone sodium super disintegrants. Evaluations indicated that synthesized BST shows qualitatively and quantitatively good disintegration characteristics in comparison to super disintegrants in telmisartan tablet formulation. These results suggest that the synthesized BST could be used as a novel semi-synthetic disintegrant in dispersible tablet formulations. Keywords: Banana Starch, Banana Starch tartrate, Telmisartan, Superdisintegrant

scholarly journals Concepts of Process Validation in Solid Dosage Form [Tablet] – An Overview

2014 ◽  
Vol 1 (1) ◽  
Author(s):  
Lakshmana Prabu S ◽  
Suriyaprakash TNK ◽  
Ruckmani K ◽  
Thirumurugan R
Keyword(s):  
Dosage Form ◽  
Process Validation ◽  
Solid Dosage Form ◽  
Solid Dosage

scholarly journals Process Validation of Oral Solid Dosage Forms - A Review

2020 ◽  
Vol 1 (5) ◽  
pp. 15-22
Author(s):  
Mariam Omari ◽  
Dr. Rashmi P ◽  
Dr. Shanthakumar G.S ◽  
Arijit Das ◽  
Pratiksha Patil
Keyword(s):  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Process Validation ◽  
Solid Dosage

scholarly journals FORMULATION AND CHARACTERIZATION OF HERBAL TABLETS FOR THE MANAGEMENT OF DENGUE

2021 ◽  
pp. 104-113
Author(s):  
Shikha Thakur ◽  
Brisha Bhardwaj ◽  
Shouvik Kumar Nandy
Keyword(s):  
Carica Papaya ◽  
Hardness Test ◽  
Herbal Extract ◽  
Angle Of Repose ◽  
Wet Granulation ◽  
Disintegration Time ◽  
Weight Variation ◽  
Phosphorus Iron ◽  
Fresh Pulp ◽  
Tapped Density

Tablets are used as formulation and are prepared by using plant extracts i.e., Carica papaya and Embelica officinalis. These tablets were prepared by using wet granulation method. In this article the extract of leaves of Carica papaya and fruits of Embelica officinalis were used for making herbal tablets. Extracts of leaves of Carica papaya was obtained by cold extraction and through maceration method and the extract of fruits of Embelica officinalis was obtained by maceration process. Both extracts were dried and mixed. These extracts were then impregnated with the excipients like diluents, binding agents, super disintegrating agent, lubricants, etc. to make granules. These granules were then evaluated by using various parameters like Angle of repose, tapped density, bulk density, Carr’s Index, Hausner’s Ratio and void volume. These granules were then used for the making of tablets of desired size and shape by punching in the machine. After preparation of the tablets their evaluation parameters were studied like physical appearance, weight variation, friability, disintegration time, hardness test and thickness. Also the parameters for the acceptance of the tablets is also done like flavor and sweetness. Recent studies have shown that herbal extract of leaves of papaya has beneficial effect as an anti-inflammatory agent, for its wound healing properties, anti-tumor as well as Immunomodulatory effects and as an antioxidant. Amla fruit is a rich natural source of vitamin C (Ascorbic acid) and contains 600-750 mg/100 g of the fresh pulp. Also it is rich in minerals matters like phosphorus, iron and calcium. Amla is used as an Immunomodulatory agent and hence enhance the immunity of the patient. Aim of the study is to design develop and optimize the dosage form to cure dengue and is based on the use of natural plant ingredients to intermingle with chemical as well as synthetic ingredients to develop an effective unit dosage forms for better patient compliance. KEYWORDS: Papaya, Amla, Extracts, Herbal tablet, Dengue, Immunomodulatory, Platelets.

scholarly journals FORMULATION AND EVALUATION OF NILAVEMBU KUDINEERCAPSULES

2019 ◽  
Vol 7 (1) ◽  
pp. 41-45 ◽  
Author(s):  
Ramanathan M ◽  
Subramanian L ◽  
Poongodi T ◽  
Manish S ◽  
Muneeswari E ◽  
...  
Keyword(s):  
Biological Activity ◽  
Herbal Medicine ◽  
Bulk Density ◽  
Water Extract ◽  
Angle Of Repose ◽  
Microbiological Activity ◽  
Weight Variation ◽  
Dried Extract ◽  
Tapped Density ◽  
Better Than

The herbal medicine Nilavembu Kudineer is very effective in viral fevers. The study was effort to prepare a Nilavembu Kudineerherbal capsule from Nilavembu Kudineer churnam. The task of this work is, to detainment of active biomolecules and ensure their biological activity. The Nilavembu Kudineerchurnamwas extracted by ethanol and water solvents, then the extract was dried. The resultant dried extract powder was screened by various chemical and microbiological tests for to ensure the potency.  The results confirms that both the extract haveactive biomolecules and possess their activity. Based on the microbiological activity NVK water extract was comparatively better than the ethanol using extract powder. The dried NVK water extract powder capsules complies with standards of capsule pre and post filling parameters such as angle of repose, bulk density, tapped density, carr’s index and hausner’s ratio. The filled NVK capsule complies the post filling evaluations of weight variation, disintegration. In future stability, dosage titrations and more number of microbial test need to conduct for their effectiveness of the formulation.  

Process Validation of Isoniazide and Rifampin Tablet

2021 ◽  
pp. 105-110
Author(s):  
Priyanka Kailas Borse ◽  
Kiran B. Dhamak
Keyword(s):  
Manufacturing Process ◽  
Critical Parameter ◽  
Tablet Formulation ◽  
Process Equipment ◽  
Wet Milling ◽  
Validation Data ◽  
Process Validation ◽  
Validation Criteria ◽  
Dry Mixing ◽  
High Degree

The plethora subscribed in this research is directed towards the process validation of tablet formulation containing Isoniazide and Rifampin. The different process parameters were identified and studied for the tablet formulation batches. Three process validation batches of same size, manufacturing process, equipment and validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

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