Manufacturing and Performing a Quality Control Test on Some Hard Shell Capsules - Lab Report Example

Lap Report – Powder Flow and Capsules Name: Course: Instructor: Institution: Date of Submission: Abstract The role of this report is to account for the effect of powder flow on capsules regarding infections cases. More importantly, it will present the importance of ensuring quality control when manufacturing capsules. It will also show how to guarantee the quality control of products while ensuring uniformity in the weight of the drugs. That is; this report is a breakdown of the laboratory exercise of manufacturing and performing a quality control test on some hard shell capsules that contain powder formulation. The experiment is to manufacture and perform a quality control test on some hard shell capsules that contain powder formulation. The trial was conducted to identify how to measure quality control while engineering hard shell capsules through using the provided sample formulation. The role of the test was to fabricate and perform a consistency of content assessment on some hard shell capsules packed with a model drug termed (ferrous fumarate) and an excipient (lactose). The method used involves preparing hard shells for manufacturing the capsules. It also comprised of the production of a batch of 60 capsules and measuring the uniformity of the drugs to ensure they pass the test. The results present the differences for measuring the weight of the empty capsules and weight of the filled capsules while showing the pass test of the randomly selected capsules. Introduction Powders are used in modern pharmaceuticals extensively. Powder Flow is the accurate flow of powder properties to ensure the uniformity and accuracy of dosages (Aulton & Taylor, 2013, 188). Powder flow is the process of ensuring that the powder mix in each tablet or capsule is same to certify the intended amount of drug is attained. Capsules are medications that manufactured as solid dosages and encased in a shell. Capsules are designed to be soluble in the gastrointestinal tract. Tablets are the most extensively used oral prescription in the current medicine. They are manufactured as hard compressed tablets that are intended to crumble in a high-water-content location such as the stomach (Goran, 2013, 507). The tablets exist in different sizes, shapes and colors to aid the patient in adherence to the medication. Both tablets and capsules are used as antibiotics or other drugs (Brian, 2013, 544). When conducting experiments on the effects of powder flow on capsules, it is important to fill the capsules with the right amount of powder ingredients to attain a quality parameter. Capsules are perceived as an oral unit dosage made of gelatin shells that are filled with the medicament. When filling the capsules, one must certify that the powder to be used to fill the gelatin does not react with the gelatin neither should it contain high levels of moisture (Brian, 2013, 585). To manufacture hard dosages such as capsules and tablets one must handle the powder to attain a reliable powder flow. Powder flowability may affect the quality of tablets and capsules as they either promote gravity or prevent cohesion (Aulton & Taylor, 2013, 197). The effective flowability of the powder affects the quality of the capsules or tablets since the powder particles affect the density, shape, size, surface area, surface texture or surface charge. Effective flowability ensures these characteristics are in equilibrium, leading to the manufacture of the accurate dosage. Quality control of tablets and capsules is thus maintained and guaranteed through the powder flowability. Effective powder flowability meets the quality control through ensuring the general appearance of the tablets; density, color distribution, and scent are accurate. Quality control of tablets involves assuring of the content and weight, disintegration, uniformity of content and labeling. Quality control of capsules is attained through the test carried out to confirm the manufactured batches pass the test (Brian, 2013). In this case, the quality control is ensured through color and weight where after the bath is finished 20 drugs randomly selected are placed under the test. The test involves calculating the mass density of the capsule content. If not more than two deviates from the average bulk, the capsules meet the quality control demand. Capsules: Method The method starts by preparing some hard-shell capsules to distribute against the medicine, ferrous fumarate 210mg, lactose qs, Mft caps #30, sig i po bds. First, one has to define the bulk of the capsule that will be engaged by the drug while considering the quantity of the medication (dose of the drug) for a specified prescription. Then, one computes the mass of the excipient needed to fill the remaining volume/bulk of the capsule. To forestall the capacity of the given mass of the drug/excipient one should attain the tapped density of the powder been used empirically. Once the masses are established, the drug can now be mixed with the excipient powder at the accurate mass ratio such that when the capsules are filled, each capsule will encompass the desired mass (dose) of the drug. The method is carried out through the supplied manual capsule filling machine and hard capsules (Brian, 2013). Quality Control of Tablets Method for Uniformity of Mass for Tablets One should precisely weigh about twenty medicines and report the mass of each. Then gauge and record the average volume of the tablets. For the tablets to pass the trial of uniformity of bulk no more than two tablets should stray from the regular mass of the percentage deviation, the tablets will pass the test. Measuring the Uniformity of Diameter To determine whether the tablets pass the consistency of diameter, one should use the calipers on condition that to measure the diameter of ten tablets randomly from the manufactured batch. One uses the calipers to assess the diameter by holding the flat faces of the tablets manufactured. To pass the uniformity of diameter, all the tablets should diverge from the average diameter by 5%. The batch that passes the test should be the only one used. Measuring the Friability To measure the friability of the tablets, one should guarantee that the friabilator is uncontaminated from any preceding models measured (Goran, 2013). Thus, one should de-dust and weigh precisely ten tablets using the 0.1mg nearest appropriate balance. Then one places the tablets on the rotational drum of the friabilator and closes the drum. Then one should revolve the drum at 25 rpm for about four minutes, and it works for about 100 cycles though it relies on the tackle used. Then one should remove the tablets from the friabilator. When any tablet comes out fractured, wrecked, cleaved it stipulates that the friability test of the sample used is unsuccessful. Then, de-dust the friabilator and re-weigh other tablets to define how many manufactured drugs pass the test, also record the mass. When reporting the total mass, one should govern the proportion mass loss. The mass loss should not surpass 1.0% to pass the trial. If the tablets outstrip a mass loss of 1.0%, then the batch has failed the friability test. Measuring the Hardness To determine the hardness of the drugs, one will have to use ten manufactured from the collection using Holland C50 or the Copley TBF 1000 hardness testers. The two tools use different operating techniques. To pass the hardness assessment, the tablets must demonstrate a hard rate within the 95 – 105% of the sample average. If the sample is within that value, the tablets have passed the test. Methods: Powder Flow: Determining Bulk Density One uses large batches of the sample powder and passes it through a 1.18mm sieve. Then, one should weigh the powder sample without compressing it into the advanced cylinder and record the mass. Without compressing, one should record the unsettled powder volume to the progressed unit. Then, one should load the graduated cylinder securely on the tapping apparatus. One should ensure that the base of the cylinder is inserted into the correct holder depending on the size of the graduated cylinder used. Then, one should press the method button and select the USP1 and USP2 depending on the gadget been used. Then, one should use the arrow buttons to pick the user on the display and then press the Set button. At the same time, one should use the arrow buttons to fix the number of taps to 50. To start the test, one should press the start button. One should perform a three series using 50 taps, recording the powder of volume after each sequence, reading to the nearest graduated unit. However, if the powder bulk differs by ≥ 2 ml between the last two sequences of the taps, one should execute an additional series of 50 taps. Then one should record the Hausner ratio and Carr’s index for the powder sample and repeat the procedure using other powder concentrations. Determining Angle of Repose To determine the angle of repose, one removes the large clumps from the powder sample using the 1.18mm sieve; and then transfer the powder sample into the funnel. Then, one should reset the height gauge to zero through placing the scriber gently in contact with the test platform by pressing the zero button and set the digital height gauge. Then one should open the shutter to allow the powder to flow on the test platform, where if the powder does not flow, one should use the stirrer and stir the powder in the funnel. Allow the excess powder to overflow into the retaining tray around the test platform. A powder cone will form on the test platform. Adjust the height of the scriber on the digital height gauge. The process will ensure that it exceeds the height out of the powder cone. Then, one should carefully, and slowly lower the scriber to the tip of the powder cone to measure the height. Lastly, one records the angle of repose and using other glidant concentrations repeat the procedure and record results. Capsules: Method for Manufacturing of Capsules One should correctly weigh (to the close 0.1 mg using the appropriate balance) five unfilled hard shell capsules counting body and cap while recording their entire mass. After measuring and recording the quantity of the empty shell capsules, one then fills the capsule/shell with the provided powder. In the experiment, the given powder is lactose BP. The capsule is filled using a capsule-filling apparatus and then re-weighed to record the mass of the content of the drug. The amount of the drug is attained by measuring the volume of the capsule when filled and deducting the volume of the empty capsule. Thus, one records the total mass and calculates the fill density of the lactose. After cleaning the capsule filling, one is anticipated to recap the method using ferrous fumarate while computing its capsule fill bulk and completing the table provided. Then, one should perfectly weigh out the powders (to the adjacent 0.1mg using a fit equilibrium) and then mix them in an airtight polyethylene bag until a uniform supply of color is reached. Then, one fills in the correct amount of hard shell capsules by using the provided manual filling machine. Measuring the Quality Control of Manufactured Capsules and Tablets Method for Uniformity of Mass Test for Capsules One should properly weigh (to the close 0.1 mg using a seemly stability) a randomly designated capsule from the manufactured batch. One should empty the fillings of the capsule and weigh the hollow capsule (body and cap) Then determine and record the change in the mass of the capsule content. Then recap the process for 19 other capsules selected aimlessly and compute the average quantity of the capsule substances. Lastly, one concludes if the capsules have passed the standardization test of mass by certifying that no more than two capsules of the 20 selected have strayed from the regular magnitude provided. Results Powder Flow: Hausner ratio as derived from the powder concentrations used was greater than 1 for all and the Carr’s index was positive for all. Hausner and Carr’s methods stipulate that the flowability of the powder in the manufactured drugs was effective. However, using the bulk density and angle of repose reports also, the flowability of the powders was determined. To determine the relationship and agreement of the powder between Hausner ratio, Carr’s index and the angle of repose, Table 1 as provided in the appendices is used. The average of Hausner ratio falls at 1.11 articulating the flowability is excellent. The average of Carr’s index falls under nine, articulating excellent flowability while the angle of repose average is at 23.5 stipulating excellent flowabilities. Capsules: The mass of the five empty capsules added to 566.1. When filled with the ferrous fumarate, the volume totaled to 6064.2. When mixed with the lactose powder, the volume was 3313.1, and the number of capsules manufactured was 60. The bulk and tapped density of both lactose and ferrous fumarate were also measured to present the flowability of the powders in the manufactured batch. Lactose had lower bulk masses when equated to the ferrous fumarate. The capacities depended greatly on the amount of sample powder used in the exercise. Carr’s index and Hausner ratio were calculated based on the powder. For instance, the as provided in Table 5, the masses of lactose and ferrous fumarate are different. The difference led to the volume variance in the exercise as presented in the experiment and recorded in the table. Discussion The flowability of the powder concentrations used and the manufacture of the capsules was excellent. After, performing the uniformity tests among others to ensure that the drugs manufactured passed the test, the tests were positive. The powder flowability passed all the tests as the methods used to measure the flowability were excellent. On the other hand, the capsules passed the test as not more than two of the tested drugs deviated from the mass average. The angle of response is used as an indirect method for quantifying the flowability of powder due to the inter-particulate cohesion (Aulton & Taylor, 2013, 196). The relationship of Hausner ratio, Carr’s index and angle of repose for the concentrated powders used stipulates that the flowability of the glidant used is excellent (Aulton & Taylor, 2013, 194). The three methods are in agreement because after measuring the flowability of the powders, the results for all were excellent. Thus, they were in agreement with the flowability of the powders. In the manufacturing of solid dosages, it is important to warrant the uniform of the powders among the products to guarantee the quality of a dosage. Inconsistency in uniform weight of manufactured drugs leads and states that poor quality of medications. The poor quality of dosages may steer to harmful health impacts and economic issues. Therefore, it is important to verify that the flowability of the powder is efficient as it regulates the size, shape and moisture content in the powder. The clinical significance of quality control in manufacturing of pharmaceutical drugs is to attest the consistency weight of the drugs to assure the dosage projected is perfect. Quality control certifies that a dosage does not have a surplus or a lower amount of the said dosage. In case the quality control is not guaranteed, the patients may have the unexpected results of consuming the products. The appropriate size of a capsule varies with the dosage specified. However, there are three most fitting magnitudes of capsules in the market for formulations of up to a diameter of 9mm. However, the most suitable diameter is 6mm, 25mm where the assortment is between 12 to 22mm. My capsule size is 00, and around the upper limit diameter size which is an applicable size in the market. Others are 000 or 00el among others. When filling the capsules it is important to assure that the powder is attuned with the gelatin to verify that no reaction occurs by forming crosslinks. Summary The flowability of the powders used was effective stipulating that they were effective for developing the capsules. After manufacturing and testing the capsules, they all passed the uniformity test stating that the manufactured batch was in excellent conditions. Manual dosing is the filling process used for the experiment; it ensures that the quantities of the capsule are accurate and consistent. The tryout found that manufacturing the capsules using ferrous fumarate and lactose provide different weights of the product. For instance, the five capsules when filled will lactose weigh 3313.1 while those that are filled with the ferrous fumarate weigh 6064.2. The powder mass of the products differs with the powder used as that of ferrous fumarate weighs more than that of lactose. However, after my experiment, I conducted the uniformity test to determine if the products had passed the test for the capsule. Not more than two of the capsules deviated from the average weight of the product, stipulating that they had passed the test and were sufficient for the set prescription. The effect of powder flow on capsules plays a vital role in ensuring the powder used in the manufacturing of the capsule is effective. Powder flowability guarantees quality control of the capsules manufactured. Appendices Table 1 Table 2: powder flow results table Glidant Conc. (% w/w) Powder mass (g) Fluff volume (mL) Tapped volume (mL) Hausner ratio Carr’s index (%) Powder height (mm) α tan α (°) 0 99.96 162 127 1.28 21.6 36.96 0.7392 36.47 0.5 100 142 128 1.11 9.86 23.55 0.471 25.22 1 100.03 144 130 1.11 9.72 24.53 0.4906 26.13 3 100.08 143 130 1.1 9.09 23.61 0.4722 25.28 Bibliography Aulton, E. M. & Taylor, K., 2013. Aulton's Phamaceutics: The Design and Manufacture of Medicines. 4th ed. New York: Elsevier Health Sciences. Brian, E. J., 2013. “Hard Capsules.”. In: M. E. A. a. K. Taylor, ed. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. Edinburgh: Churchill Livingstone/Elsevier, p. 583–96. Goran, A., 2013. Tablets and Compaction. In: 4. e. Michael E Aulton and Kevin Tayloy, ed. Aulton's Pharmaceutics: The Design and Manufacture of Medicines. Edinburgh: churchil Livingstone/Elsevier, pp. 504-49. Read More