Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Hasan, Md. Imtiaz; Shimu, Shahnaz Akter; Akther, Akhi; Jahan, Ishrat; Hamiduzzaman, Md.; Hasan, A. H. M. Nazmul

doi:10.4236/jbm.2021.910003

Cited by 4 publications

(6 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…31 Different countries have varying regulatory agencies responsible for overseeing drug manufacturing. 32 Some countries have strict and well-established regulatory bodies, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which enforce stringent quality control measures. 33 Other countries may have less stringent regulations, leading to variations in manufacturing practices.…”

Section: Resultsmentioning

confidence: 99%

A comprehensive review addressing the factors influencing generic drug substitution

Jouni,

Mansour,

Hatem

et al. 2023

Journal of Generic Medicines

View full text Add to dashboard Cite

Generic drug substitution is a common practice in healthcare systems worldwide to promote cost-saving treatments while maintaining therapeutic effectiveness. Several factors influence this substitution, including regulatory policies, safety and efficacy considerations, patient and physician preferences, and market dynamics. This review comprehensively analyzes how these factors interact and influence generic drug substitution in healthcare settings and across various therapeutic classes and highlight the importance of balancing cost-saving measures with maintaining patient safety and therapeutic efficacy. Policies and guidelines established by health authorities in each country influence the approval, interchangeability, and substitution of generic drugs. Bioequivalence and therapeutic equivalence are critical factors, particularly in drugs with narrow therapeutic indexes. Moreover, physicians’ acceptance and willingness to prescribe generic drugs, as well as patient acceptance and compliance with generic drug use, play a vital role in promoting generic substitution.

show abstract

Section: Resultsmentioning

confidence: 99%

A comprehensive review addressing the factors influencing generic drug substitution

Jouni,

Mansour,

Hatem

et al. 2023

Journal of Generic Medicines

View full text Add to dashboard Cite

show abstract

“…Linearity: Response of the all components was found to be linear in the investigation concentration range and the linear regression equations were reported with correlation coefficient 0.99 for all components. (Table 3, 7,11,15). LOD and LOQ: lowest limit of detection and highest limit of detection were calculated for all components and reported.…”

Section: Resultsmentioning

confidence: 99%

“…For the generic formulation to get similarity in performance with respect to RLD, (3) It is necessary to know the qualitative and quantitative composition of RLD this can be possible by decoding the formula of RLD. (4)(5)(6)(7) Rising deaths due to prescription and illicit opioid overdose was an alarming situation in USA. Although opioid reversal injection is also available which safe and efficacious treatment for opioid overdose is, it is sometimes unavailable on https://jrtdd.com time due to legal and practical restrictions for layman.…”

Section: Introductionmentioning

confidence: 99%

Design And Development Of Generic Formulation By Applying Reverse Engineering Approach

R. L.,

W. N.,

T. M.

et al. 2023

JRTDD

View full text Add to dashboard Cite

Introduction:The innovator formulation is meat for its high cost as Innovator Company used to invest millions of dollars. The generic formulation is an alternative to beat the cost. The criteria of generic formulation is should have the bioequivalence as that of RLD (Reference Listed Drug). Reverse engineering is decoding of the RLD to find out qualitative and quantitative composition. Rationale behind reverse engineering is if qualitative and quantitative composition of the formulations is same then performance of the formulation will also be same. That helps to speed up the process of generic formulation development and reduces cost and time. The formulation used in study is anti-opioid uni-dose nasal spray 4mg/0.1ml. The formulation contains of anti-opioid drug, benzoalkonium chloride(BKC), EDTA, sodium chloride (NaCl) and pH adjusters like hydrochloric acid, sodium hydroxide. Objectives: The main objective of current research is to perform reverse engineering of RLD to find out the qualitative and quantitative composition by using different analytical methods and validate the same as per ICH guideline. To develop generic formulation by using data obtained from reverse engineering. To perform similarity matrixing for inhouse and RLD formulation. Methods: Different analytical methods were used to perform the reverse engineering of the RLD to find out the qualitative and quantitative composition like HPLC for benzoalkonium chloride and EDTA. Flame photometry for the NaCl, and the Nano-drop UV for the Anti-opioid drug. The Assay, pH, osmolarity and viscosity were performed for complete characterization of the RLD while for in-house to show the similarity matrixing. Results: The de-formulation was performed for all the components and the methods were validated as per ICH guideline. The correlation coefficient was >0.99 for all components in all the methods. The recovery results ranged from 99.4 to 99.6% for anti-opioid drug, 99.83−100.33% for BKC, 100.02−100.23% for NaCl and 100.3−100.7% for EDTA. The obtained % RSD for precision study were 0.87% (intraday) and 0.76% (interday) for anti-opioid drug, 0.01% (intraday) and 0.1 (interday) for BKC, 0.62% (intraday) and 0.54 (interday) for NaCl and 0.62%(intraday) and 0.54 (interday) for EDTA. There were no interference of other components and methods are specific. Conclusions:The reverse engineering gave critical information about the formulation apart from qualitative and quantitative composition like process used by innovator to stabilize the formulation, viscosity of formulation and mechanism of uni-dose nasal spray to provide the better efficacy. That saves time, cost and manpower incurred for the trial batches. The validation of methods gave an assurance for the qualitative and quantitative composition helped for getting affordable bioequivalent generic formulation.

show abstract

“…Pharmaceutical companies develop generic drug products using a scientific and technical methodology that is entirely distinct from the methodology used to create innovator or reference products (Hasan et al, 2021). The main difference is that generic drugs should have a BE test result to confirm the efficacy equivalent of two products.…”

Section: Limitationsmentioning

confidence: 99%

“…In Thailand, new generic drug development follows the Association of Southeast Asian Nations (ASEAN) harmonization and the ASEAN common technical requirement (ACTR), which states that pharmacists must develop new generic drugs with a pharmaceutical equivalent, quality control of raw materials, product, and packaging, and evidence of product interchangeability equivalence. Developing a new generic drug product in the pharmaceutical industry requires a scientific and technical approach that is distinct from developing an innovative prod-uct (Hasan et al, 2021). The goal of developing a new generic drug should be to have the same pharmaceutical properties, treatment efficacy, and safety as the original product (Davit et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

Development of Pharmaceutical Equivalent Montelukast Sodium Immediate-Release, Film-Coated Tablets

Muenraya,

Atipairin,

Srichana

et al. 2024

Sci. Technol. Indones

View full text Add to dashboard Cite

Montelukast tablets are sold under the brand name Singulair and are used to control and prevent asthma symptoms. In this study, 10 mg film-coated montelukast tablets were developed as a generic drug in order to evaluate the pharmaceutical equivalent of the innovator’s products. The primary formulation ingredients used in all developed formulations (F1-F5) were the same as those described in the Singulair tablet package insert, except for formulations F3, F4, and F5, to which solubilizing enhancers were added to increase montelukast solubility. The core tablets were produced using the wet granulation method before being coated with HPMC polymer. FT-IR and DSC were used to determine drug and excipient compatibility. The micromeritic properties of the granules were assessed. The physicochemical properties of generated montelukast tablets and Singulair tablets were also investigated. The dissolution profiles of the tested drug and the innovator were assessed in a variety of pH mediums (pH 1.2, 4.5, 6.8, and water). The similarity (f2) and difference (f1) factors were computed. The accelerated and long-term stability of the tested drug in hot and humid climate zones was evaluated. The analytical method validation used in this study was ICH-acceptable for 8 parameters including specificity, range, linearity, accuracy, precision, limit of detection, limit of quantitation, and robustness. F1-F5 granules had similar properties, such as a pale-yellow color and excellent flow properties. There were no chemical interactions between montelukast and the excipients according to FT-IR and DSC analyses. The physical properties of all developed montelukast film-coated tablets were similar (average weight 212-218 mg; thickness 3.02-3.07 mm; assay 101-102% LA; disintegration time 3-4 min), except that the disintegration time of F3 was 8.10 min and that of F5 was 5.90 min, which was caused by the addition of poloxamer 188 to the formulation. In all mediums, only the F1 formula produced acceptable comparison dissolution profiles to Singulair. After 6 months of storage under accelerated and long-term conditions, the results showed the F1 formulation remained physically and chemically stable.

show abstract

Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Cited by 4 publications

References 10 publications

A comprehensive review addressing the factors influencing generic drug substitution

A comprehensive review addressing the factors influencing generic drug substitution

Design And Development Of Generic Formulation By Applying Reverse Engineering Approach

Development of Pharmaceutical Equivalent Montelukast Sodium Immediate-Release, Film-Coated Tablets

Contact Info

Product

Resources

About