Formulation And In-Vitro Testing of Quick Dissolving Tablets of Nsaids Drug Along with Musa Paradisiaca Powder

Quick dissolving tablets (QDTs) are a popular dosage form for patients who have difficulty swallowing conventional tablets. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are commonly used to treat pain and inflammation. Musa Paradisiaca is a natural superdisintegrants that can enhance the dissolution rate of QDTs.

The inability to swallow is a typical occurrence in elderly patients because of dysphasia, hand tremors, and choking fear. It is also common in younger people because of immature muscular and neurological systems and in patients with schizophrenia, which results in poor patient compliance. Swallowing problems affect about one-third of the population, primarily young and old.

This causes poor adherence to oral tablet medication therapy, which lowers the effectiveness of therapy as a whole. Because of this, there has been a lot of interest in tablets that can quickly dissolve or disintegrate in the oral cavity [1]. Quick dissolving drug delivery systems were first developed in the late 1970s as an alternative to conventional dosage forms for the pediatric and geriatric patient. These tablets are designed to dissolve or disintegrate rapidly in the saliva generally less than 60 seconds [5]. To fulfill these medical needs, pharmaceutical technologists have developed a novel oral dosage forms known as orally disintegrating (dispersible) tablets (ODTs) or Quick disintegrating (dissolving) tablets (QDTs) or mouth melting tablets Formulating QDT can be done in a number of ways. Direct compression is one of the methods that requires the addition of highly water-soluble or super disintegrate excipients to the formulation for a specific reason in order to achieve rapid tablet disintegration. For medications that are susceptible to moisture and heat, direct compression is the best option because it eliminates the need for heat or water during the formulation process. [4] Certain medications may have a higher bioavailability because of oral drug absorption as well as pregastric absorption of drug-dispersed saliva that travels down into the stomach. Furthermore, compared to a normal tablet, less medication is vulnerable to first pass metabolism.

Advantages of Quick Disintegrating Tablets [7]

1. Simple administration for patients, such as pediatric, geriatric, and mental patients, who refuse to take a tablet.

2. Patients who are traveling and do not have access to water will find this function incredibly helpful since it requires little or no water to switch the dosage.

3. Better safety since there is no chance of suffocation from a physical blockage when ingested.

4. The medicine will dissolve and absorb quickly, resulting in a prompt commencement of effect.

MATERIAL AND METHOD:

FTIR studies

The IR spectra were recorded using an FTIR spectrophotometer (Shimadzu, Japan) with diffuse reflectance principle .The samples were scanned over the frequency range 4000–400-1cm.

Differential Scanning Calorimetry (DSC)

Differential Scanning Calorimetry (DSC) studies were carried out using DSC 60, having TA60 software, Shimadzu, Japan. Samples were accurately weighed and heated in sealed aluminum pans at a rate of 10°C/ min between 40 and 350°C temperature rang under nitrogen atmosphere. Empty aluminum pan was used as a reference.

Stability studies

The optimized SD sealed 40cc HDPE container and placed in         restricted environment in stability chamber (Thermo Lab, India) at 75%±5%RH and 40 0C±20C. Samples analyzed at the end of 1st, 2nd and 3rd months for drug content and drug release.

Preparation and evaluation of lornoxicam qdt

Quick dissolving tablet of Lornoxicam were prepared by direct compression method. Pure drug and excipients were passed through # 60 No. mesh, required amount of drug and excipients were taken for every formulation. The powdered drug, Mannitol and Lactose were mixed uniformly with continuous trituration using mortar and pestle. Then weighed quantity of super disintegrates and aspartame taken for each formulation and properly mixed, finally magnesium stearate and talc powder were added and mixed well. The mixed blend of drug and excipients were compressed using 10 station tablet punching machine. A Batch of 50 tablets of each formulation was prepared for all the designed tablet formulations. Before the tablet preparation /punch the mixture blend of all designed formulations were subjected to compatibility studies (IR) and pre-compression parameters like- Angle of repose, Bulk density, Tapped density, compressibility index, Hauser’s ratio.

Table 2: Formulation trials of Lornoxicam of Quick disintegrating tablets

RESULT AND DISCUSSION

Characterization of lornoxicam QD

Ftir Studies

The FTIR spectra of Lornoxicam and compare it with the formulation at 3,333 cm-¹ (NH stretching), 1,690 cm-¹(C=O stretching), 1,529 and 1,492 cm-¹ (which were assigned to bending vibrations of the N-H group in the secondary amide) 1,190, 1,387, and 1,350 cm-¹ (O=S=O group stretching), 829.42 cm-¹ (-CH aromatic ring bending) and 744.55 cm-¹ (C-Cl vibration bending). The distinguishing IR peaks of Lornoxicam were not distorted in the optimized formulation, signifying no chemical interactions amid the drug and excipients.

DSC studies

The DSC of Lornoxicam containing marketed tablet (Lorsaid 8 mg) displays a sharp endothermic peak at 229 ⁰C which is its melting point, indicating crystalline nature of the drug. The absence of drug peak in QD3 indicates that the drug is converted into amorphous form. The decrease in intensity of the endotherm of QD7 signifies quicker drug dissolution from the solid dispersion that attributed to the decline in crystallinity of the drug. Crystallization inhibition is attributed to the entrapment of the drug molecules in the polymer matrix during solvent evaporation.

Physico-chemical evaluation of lornoxicam QDT

The results of bulk densities formulations bearing QD 1 to QD 7 reported being in the range of 0.51g/cc to 0.58g/cc. The findings of tapped density formulations QD 1 to QD 7 reported being in the range of 0.51g/cc to 0.71g/cc. The angle of repose of all the formulations was found a satisfactory result. The formulation QD 3 was found to be 24.22 having good flow property. The compressibility index values were found to be in the range of 9 to 13 %. These findings indicated that the all the batches of formulations exhibited good flow properties. The Hausner’s ratio values in the space of 1.01 to 1.06 %. These findings designated that the all the batches of formulations advertised good flow criterions.

Percentage cumulative drug release

The % CDR of all the formulations QD 1 – QD 7 are. The study indicate that the drug release of all the formulations ranged between 84.26±1.11 to 97.21±1.87% in 10 hours .The maximum drug release is exhibited by QD 3 (97.21±1.87%) that is higher than the release value of marketed formulation (92.76±1.53%).

Stability studies

The optimized formulation evaluated for stability for 6 months as per ICH guidelines. The results conclude that the formulation is stable and retained all their original properties like hardness, and dissolution studies with minor variations

Table 3: Stability studies of optimized formulation