scholarly journals Fixed dose combination products as Oro-dispersible tablets: A review

2019 ◽  
Vol 9 (2) ◽  
pp. 563-573
Author(s):  
Gothainayaki Chandrasekaran ◽  
A.N. Rajalakshmi
Keyword(s):  
Patient Compliance ◽  
Pediatric Patients ◽  
Psychiatric Patients ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Orally Disintegrating Tablets ◽  
Wide Range ◽  
Swallowing Problems ◽  
Commercial Market ◽  
Dose Combination

A fixed-dose combination (FDC) drug is a one that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses [1]. It increases patient compliance by reducing the no. of medications that a patient has to take especially for geriatric and pediatric patients. Orally disintegrating tablets (ODTs) are solid dosage forms containing a medicinal substance or active ingredient that rapidly disintegrates upon contact with saliva, typically within 30 s, eliminating the need for swallowing. It also increases patient compliance by reducing the swallowing problems faced by the patients especially for geriatric and pediatric patients. This review is about combining the techniques of both FDC and ODT formulations which promises to have a wide range of advantages to pediatric and geriatric populations, institutionalized and psychiatric patients, those suffering from nausea and vomiting, and individuals with lack of access to water. In spite of these advantages rarely do we find FDC-ODT products in our commercial market, this review aims at analyzing all the aspects of FDC and ODT formulations thereby forming the foundation for further studies. Keywords: Fixed-dose combinations, Orally disintegrating tablets, Patient compliance.

scholarly journals Importance of patents and data exclusivity in fixed-dose combination medicinal products

2019 ◽  
Vol 65 (2) ◽  
pp. 33-38
Author(s):  
Marija Mitkovska ◽  
Katerina Anchevska Netkovska ◽  
Aleksandra Grozdanova ◽  
Ana Poceva Panovska ◽  
Ema Kikovska Stojanovska
Keyword(s):  
Data Protection ◽  
Developed Countries ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Medicinal Products ◽  
Active Compounds ◽  
Intellectual Property Rights Protection ◽  
Data Exclusivity ◽  
Wide Range ◽  
Dose Combination

The efficacy of an active compound can be advantageously improved when combined with other active compounds. Medicinal products for a particular indication(s) that contain combination of two or more active compounds in a fixed dose ratio is so called fixed-dose combination medicinal products or FDCs. FDCs are beneficial for patients’ adherence to the treatment because of the simplified drug regimen. They are used in the treatment of a wide range of medical conditions especially in the treatment of chronic illnesses including AIDS, type 2 diabetes, and many cardiovascular diseases. FDCs as other medicines are subject to variety of intellectual property rights protection (IPRs), including patents and data protection. Different jurisdictions worldwide have different standards when determining the eligibility of FDCs for patent and/or data protection. They can vary from 1) cases with lower standards for assessing the inventive step, where FDCs are given additional combination patent rights, 2) cases where FDCs is given status of new chemical entities thus allowing supplementary protection certificates and 3) cases where additional data protection for FDCs of already known active compounds is allowed. In this study, we have assessed the national standards among different jurisdictions of developing and developed countries. A comparison of their approaches in respect to their benefits and deficiencies related to the originators, patient accessibility and public health policies has been made. Key words: Fixed-dose combination medicinal products, patents, data exclusivity

scholarly journals Formulation and Optimization of Monolithic Fixed-Dose Combination of Metformin HCl and Glibenclamide Orodispersible Tablets

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Anteneh Belayneh ◽  
Fantahun Molla ◽  
Getu Kahsay
Keyword(s):  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Pill Burden ◽  
Compression Force ◽  
Disintegration Time ◽  
Peg 6000 ◽  
Ir Studies ◽  
Orodispersible Tablets ◽  
Swallowing Problems ◽  
Dose Combination

The treatment of type II DM involves the use of combination of drugs, especially at the chronic stage. However, the pill burden of this combination therapy combined with swallowing difficulties, occurring at a later stage of DM, has been the major challenge for successful treatment outcomes. This study was aimed at formulating and optimizing a monolithic fixed-dose combination (FDC) of metformin (MET) and glibenclamide (GLB) orodispersible tablets (ODTs) to overcome both the pill burden and swallowing problems. The FDC ODTs were prepared by the melt granulation technique using polyethylene glycol (PEG) 6000 as a binding agent and crospovidone as a superdisintegrant. In the preliminary study, the effects of sodium lauryl sulphate (SLS), PEG 6000, crospovidone, and compression force on friability, disintegration time, and drug release of tablets were investigated. The FT-IR studies showed that there were no incompatibilities between MET and GLB as well as within excipients. The preliminary studies revealed that PEG 6000 and compression force significantly affect both the friability and the disintegration time, while SLS and crospovidone only affect the disintegration time. Therefore, the effects of PEG 6000, crospovidone, and compression force were further studied and optimized using the central composite design. Accordingly, the most desirable optimal values were obtained at 3.82% of PEG 6000, 9.83% of crospovidone, and 10.6 kN compression force having a friability of 0.302% and a disintegration time of 18.7 seconds. From these results, it can be concluded that a monolithic FDC of MET and GLB ODTs having adequate mechanical strength and faster disintegration time was successfully formulated.

A New Fixed-Dose Combination for Added Blood Pressure Control: Telmisartan Plus Hydrochlorothiazide

2002 ◽  
Vol 30 (4) ◽  
pp. 366-379 ◽  
Author(s):  
Y Lacourcière
Keyword(s):  
Blood Pressure ◽  
Cost Effective ◽  
Pressure Control ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Angiotensin Ii Receptor Blocker ◽  
Angiotensin Ii Receptor ◽  
Wide Range ◽  
Dosing Regimens ◽  
Dose Combination

Population surveys on hypertension management reveal worrying deficiencies in the awareness and treatment of high blood pressure. Many patients with hypertension will require two or more drugs with complementary mechanisms of action (which generally have additive effects, producing greater blood pressure reductions than either agent alone) to attain the blood pressure goals specified in internationally accepted guidelines. Nevertheless, physicians are often reluctant to prescribe multiple anti-hypertensive drugs due to concerns over side-effects, inconvenient dosing regimens and costs. Fixed-dose formulations combining two agents from different classes in a single tablet should help to allay these concerns. A fixed-dose combination containing telmisartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic) has recently been developed. Telmisartan/hydrochlorothiazide provides additional anti-hypertensive efficacy compared with the respective monotherapies in a wide range of patients, including black patients, requires once-daily dosing, is cost-effective, well tolerated and is associated with less potassium depletion than hydrochlorothiazide administered alone.

scholarly journals Knowledge, attitude and practice regarding use of fixed dose combination drugs among young prescribers a tertiary care teaching hospital in rural Bengal, India

2019 ◽  
Vol 8 (7) ◽  
pp. 1479
Author(s):  
Ananya Mandal ◽  
Sonai Mandal ◽  
Somenath Das
Keyword(s):  
Patient Compliance ◽  
Synergistic Effects ◽  
Tertiary Care ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Cross Sectional ◽  
Medical College ◽  
Prescribing Practice ◽  
Dose Combination ◽  
Graduate Trainees

Background: Use of fixed dose combination (FDCs) is a double edged sword with scope for irrational prescribing on one hand and improved pharmacotherapy and patient compliance on the other hand. Irrational FDCs are being marketed aggressively and often young prescribers including Post Graduate Trainees fall prey to the lure of FDCs. This was a Knowledge-Attitude-Practice study regarding of FDC use among the resident doctors working at a tertiary care medical college of rural Bengal.Methods: This was a cross-sectional, questionnaire based study including 50 resident doctors who were asked to fill a 10-question questionnaire on FDCs anonymously.Results: Ninety two percent of the study participants were aware of the FDCs. The most commonly perceived advantages were better patient compliance and synergistic effects. Most (96%) cited problems of titrating dosages and problems of more side effects. Only 37.6% knew about the banned FDCs. Preferred FDCs among them were antibiotics (94%), cough syrups (80%) and NSAIDs (68%). Residents of dermatology, orthopaedics, surgery and medicine most commonly prescribed FDCs. Sources of knowledge regarding FDCs were CME (92%), medical representative (76%), colleagues (72%), internet (68%), journals (48%) and textbooks (36%).Conclusions: The study showed that most participants were aware of the FDCs and also aware of the problems with irrational FDC use. Knowledge regarding banned drugs was poor as was the rationality of such combinations. More CMEs and inter department group discussions could be conducted to improve awareness and FDC prescribing practice among young prescribers.

Sign in / Sign up

Export Citation Format

Share Document