This term has traditionally been applied to semisolids that possess a relatively fluid consistency formulated as either waterinoil e. Stir a quantity of ointment, equivalent to 300 mg of lidocaine, with 20 ml of water, transfer to a separator, and extract with two 30ml portions of solvent. The specific technique employed is determined by the dosage form itself and the intended route of delivery. In the past few years, however, these forms also have been. Quality factors influencing semisolid manufacturing wdprx. In vitro release testing and in vivo bioequivalence documentation guidance.
Depending on the use of the dosage form the dosage form e. Quality control tests for topical preparations slideshare. In vitro release testing of semisolid dosage forms dissolution. Detection, measurement and control in the manufacturer of pharmaceuticals topical semisolid dosage forms product quality and product performance testing clarence t. Content uniformity test was developed to ensure content consistency of active drug substances within a narrow range around the label claim in dosage units. Semisolid dosage forms include ointments, creams, or gels. The measurement of drug release from a given dosage form is fundamental to drug product development. In the past few years, however, these forms also have been explored for the systemic delivery of various drugs. The semisolid drug category is comprised of creams, gels, ointments, suppositories, and other special topical dosage forms. Performance testing for topical and transdermal drug delivery. Quality factors influencing semisolid manufacturing. Quality control requirements for semisolid dosage forms ointments, creams, jellies and suppositories.
Dec 01, 2016 the skin is a commonly used route of administration for pharmaceutical products for both systemic and topical action. Introduction to dosage forms march 1, 20 september 19, 20 saypeople 0 comments education, multiple choice questions mcqs, pharmaceutics, pharmacy, quiz you can find the quiz below and remember there can be more than one answers. Quality control tests for topical preparations under the guidance of presented. In general, an in vitro dissolutionrelease test is expected for each novelspecial dosage form regardless of whether the intended effect is systemic or nonsystemic e. Pdf in vitro release testing of semisolid dosage forms. Used primarily for solid oral dosage forms, this test has expanded to a variety of novel or complex dosage forms as drug delivery becomes more complex. That test employs the vertical diffusion cell vdc system. The main criteria for quality of any drug in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. The type of microbial test s and acceptance criteria should be based on the nature of the drug substance, method of manufacture etc. This test is crucial for tablets having a drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total tablet weight.
They can be applied topically to the skin, cornea, rectal tissue, nasal. Main structurefom1ing materials for semisolid dosage form. Permeation the transmission of gases, vapors or liquids from the surrounding environment into the plastic container is known as permeation. Quality control test of solid dosage form authorstream. Although fda and the european medicines agency ema introduced pharmaceutical quality by design qbd in international guidelines a few years ago, most drug developers remain unaware that the real. Quality control of sgc is crucial to ensure the products intended invivo performance, and a variety of quality control tests are available to use for evaluation 2, 3. This will permit the easiest tracking of dissolution data for the conversion from capsule. Apart from the usual pharmaceutical ingredients such as preservatives, antioxidants, and solubilizers, the basic constitue nts of a semisolid dosage form are unique to its composition. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.
Quality by design approaches for topical dermatological dosage forms arunprasad sivaraman, ajay k banga department of pharmaceutical sciences, college of pharmacy, mercer university, atlanta, ga, usa abstract. Different types of dosage forms in pharmaceuticals. Testing of semisolids and other nonoral dosage forms semisolids the requirement for testing the release rate of drugs from semisolid dosage forms has increased in recent years. Particle size and size distribution play an important part in manufacturing processes such as blending, flow property, and tablet compression of solid dosage forms tablet and capsule as does physical stability in the manufacture of semisolid dosage forms ointment, cream, and suspension. Topical and transdermal drug products official november 1, 20 sterility. Creams are semisolid dosage forms that contain one or more drug. The quality control tests remove the damaged or broken tablets or which are unblinded to the ingredient. Creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base. A pharmaceutical tablet must satisfy certain standards to claim it to be a quality drug. However, the formula ranges, physical and chemical specifications of the drug substance and excipients, inprocess variables, interaction effects of the dosage form ingredients under normal and stress aging conditions, should be confirmed by limited challenge in pilot. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another. The microbial quality control of the drug product needs to be considered, especially in waterrich formulations. Sometimes the dosage form used in an early phase may be different from the final commercial dosage form.
Jan 15, 2018 this story appears in the january 2018 issue of contract pharma magazine. At present, a product performance test exists only for semisolid formulations, speci. Supacss stands for fdas guidance for industry on nonsterile semisolid dosage forms for scaleup and post approval changes and was issued in may of 1997. The critical quality attributes are efficient openingrupture, disintegration, and appropriate dissolution in biological fluid. Systemic therapies are delivered via transdermal drug products tdps which release an active ingredient through the skin into the bloodstream. Semisolid dosage forms are drug products of semisolid consistency intended to be topical applications to skin or mucous membranes, such as the eye surface, the buccal area, the nasal mucosa, and the rectal and vaginal tissues. The quality of a pharmaceutical tablet needs to be designed from the product development stage. Pdf dissolution testing of semisolid dosage forms researchgate. The quality control tests of these tablets depend on the nature of the tablet. The drug released from a semisolid dosage form in which the drug is completely dissolved is described by the higuchi diffusion equation. Edward lau deceased, in separation science and technology, 2001.
Because these formulations, including semisolids, have become more prevalent, there has been an increase in development of this testing. Review article semi solid dosage forms manufacturing. Introduction ideal properties of semisolids categories of semisolids evaluation of ointments evaluation of creams evaluation of suppositories conclusion references draize skin irritation test. Alteration on the properties of plastics or product 1. Annex 4 who guidelines for sampling of pharmaceutical. Semisolids are available as a wide range of dosage forms, each having unique characteristics 2. Different parameters of quality control of pharmaceutical products can ensure the quality, bioavailability and optimal therapeutic activity. Evaluating a new quality control test for soft gelatin rectal. Guidance for industry food and drug administration. Two categories of tests, product quality tests and prod uct performance. It is one of the most important ingredient used in formulation of semisolid dosage form. While such dosage forms afford distinct costsaving and convenience advantages, contamination in these multidose containers pose a significant risk as a source for nosocomial infections.
The most important criteria for quality of any drug in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. Dosage form plastic interactions limitations of plastic materials. This is the official test which testifies the time required for a tablet to disintegrate in the solution. Quality factors influencing semisolid manufacturing the manufacture of semisolid dosage forms requires specialized production techniques to assure high quality results bulk homogeneity for semisolid ingredients is achieved with correct and appropriate use of tanks, agitators, scraper blades and other manufacturing equipment. The quality by testing qbt technique used by the pharmaceutical industry to. The development of a solid dosage form will be dependent upon the specific product and process. Creams, ointments, and gels generally are referred to as semisolid dosage forms. There are many dosage forms available in the markets in many brands.
It reflects the effects such as temperature and storage time. What are the challenges for manufacturers in ensuring quality throughout a solid dosage or semisolid dosage products entire lifecycle. Quality control test for tablets disintegration test. Contents of the powerpoint on evaluation of semisolid dosage forms include. Semisolid dosage forms usually are intended for localized drug delivery.
Inprocess and finished products quality control tests for. Tekade, in dosage form design considerations, 2018. Semisolid dosage form an overview sciencedirect topics. Development and validation of in vitro release testing for. Quality control requirements for pharmaceutical dosage forms. It helps in understanding the physicochemical nature of the vehicle and the quality control of ingredients, test formulation and final products, together with manufacturing process such as mixing, milling, pumping, stirring, filling and sterilization. Figure 1 shows the basic raw materials used in the development of.
Quality factors influencing semisolid manufacturing kalpen patel, research and development manager, wdprx angela holley, business development director, wdprx although the name suggests otherwise, manufacturing semisolid pharmaceutical drug products cannot be done halfway. Semisolids constitute a significant proportion of pharmaceutical dosage forms. University of nebraska medical center college of pharmacy december 2, 2010. However, the formula ranges, physical and chemical specifications of the drug substance and excipients, inprocess variables, interaction effects of the dosage form ingredients under normal and stress aging conditions, should be confirmed by limited challenge in pilotscale. Aug 27, 2016 quality control tests of semisolid products dr. Quality factors influencing semisolid manufacturing contract.
This story appears in the january 2018 issue of contract pharma magazine. Ensuring quality in solid and semisolid dosage forms. The quality of a pharmaceutical dosage form is the foremost criterion during the development of a product. Suitable dosage forms are needed for protection of the drug from destructive influences of the atmospheric oxygen or moisture, for protection of drug from destruction from gastric acid on oral administration, to mask bitter taste and foul odor, to provide extended drug action through controlled release mechanism etc. Ointment and suppository bases do not merely act as the carriers of the medicaments, but they also control the extent of absorption of medicaments incorporated in them. Specific testing of semisolid formulations maintains quality control and.
The manufacture of semisolid dosage forms requires specialized. The release of an api from semisolid dosage forms is an important quality control tool. A known amount of test substance is introduced under a one square inch gauge patch, the patch is applied to skin. Guidance for industry nonsterile semisolid dosage forms. Quality control analysis is to regularly check in each step to produce a good quality of the products. Quality control qc is an historical process in which proof is obtained that the appropriate level of quality has been achieved. Products tested include ointments creams pastes gels lotions 212 21 dissolution apparatus semisolids usp has recently may, 2012 published a proposed general. Tdps have high patient acceptability, enable steady, controlled delivery over a prolonged period and offer the additional benefit of. In vitro bioequivalence data for a topical product. Therefore, the in vitro release test for those products also may differ signi.
Semisolid products have been manufactured for many years for distribution as pharmaceutical drug products, cosmetics and health supplements. A simple and reproducible method using vertical diffusion cell vdc systems and a synthetic membrane that could be readily adopted for the quality control of semisolid products was first developed and demonstrated by shah et al. Maryam kazemi phd student of pharmaceutics shiraz university of medical sciences 3 4. The fda has stated in the supacss guidance document that in vitro release testing has shown promise as a means to comprehensively assure consistent delivery of the active components. For solid dosage forms, dissolution testing has been used for the past 50 years 1. Qc can have no effect on the quality of the pharmaceuticals. The type of microbial tests and acceptance criteria should be based on the nature of the drug substance, method of manufacture etc. Details of drug product quality tests for semisolid drug products can.
Dosage forms also called unit doses are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components, in a particular configuration such as a capsule shell, for example, and apportioned into a particular dose. Quality factors influencing semisolid manufacturing the manufacture of semisolid dosage forms requires specialized production techniques to assure highquality results bulk homogeneity for semisolid ingredients is achieved with correct and appropriate use of tanks, agitators, scraper blades and other manufacturing equipment. Although fda and the european medicines agency ema introduced pharmaceutical quality by design qbd in international guidelines a few years ago, most drug developers remain unaware that the real benefits of. Semisolid dosage forms products intended to be applied on skin epicutaneous route and mucous membranes cling to the skin or mucous membrane for a prolonged period of time to exert their therapeutic benefits.
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