The term “quality control” in the pharma industry is the comprehensive reference for all procedures that ensures the identity and purity of the pharmaceutical product. The QC procedures may be diverse, ranging from reviewing the performance through chemical experiments or packaging the products safely. All these determine the identity and review the presence of specific pharmaceutical substances. Apart from the solid capsules and medical equipment, one must find a tailor-made testing solution for liquid-based drugs. The QC measures for reviewing the ingredients are an integral part. But there is more. For instance, reviewing the viscosity is a prominent part of QC measures for pharmaceutical syrups and liquid medications.
Liquid-based pharmaceutical products and drugs are of more than one type. It could be classified into three sub-groups – solutions, emulsions, and suspensions.
- Pharmaceutical solutions – These are homogeneous mixtures that do not exhibit the sedimentation of particles. Pharmaceutical solutions contain a soluble material dissolved in a liquid or solvent. It looks lucid. A typical example would be a sugar-water solution. These solutions could be categorized into aqueous solutions, including douches, mouthwash, nasal wash, etc., and non-aqueous solutions, including elixirs, spirits, collodions, cough syrup, etc.
- Pharmaceutical emulsions: These are biphasic systems with immiscible liquids. The liquid is thermodynamically unstable and needs to get stabilized with the help of an emulsifying agent. Examples of pharma emulsions include the products used for the treatment of skin conditions and skincare.
- Pharmaceutical suspensions: The pharma suspensions are heterogeneous mixtures with solid particles less than 1000 nm that settle down. An ideal suspension is stable during storage, but it needs to settle slowly. Drugs with low solubility are pharmaceutical suspensions. A suspension may delay the functionality of a drug, preventing the swift degradation in the presence of moisture.
QC with viscosity check for pharmaceutical syrup
The syrup is a pharma product everyone has seen. It may be a cough syrup or any other drug-based solution. It is a concentrated, aqueous solution containing sugar or its substitute without flavors. The flavor is optional. The syrup can contain one or multiple active ingredients in the solution. Such a solution is a syrup with 85% sucrose concentration. It is essential to prevent bacterial growth.
The viscosity of cough syrup must be high. But it must be drinkable with a swift-flowing nature for the digestive tract. One can evaluate the flow behavior of cough syrup through a rotational viscometer.
- Consistency index ‘k’ in viscosity – The parameter, ‘k’ represents the pharma syrup’s viscosity at rest in the bottle.
- Flow index ‘n’ – This parameter. ‘n’ determines the flow behavior of the pharma syrup. If n is less than one, the product would exhibit a shear-thinning behavior. The apparent viscosity reduces with the increase in the shear rate.
It is vital to ensure the operability and consistent quality of the syrup with a reliable test report. One can ensure optimal customer satisfaction and consistent quality for the produced batch to batch with the accurate data of flow index and consistency index.
Essentiality of viscosity in pharmaceutical syrup
Why do you think viscosity plays a critical role in the manufacturing steps of a syrup batch? It determines the consistency and quality.
- If the viscosity of syrup is low, there would be an issue with filling the syrups in bottles. In fact, the syrup may flow out of the bottleneck while filling it with pressure.
- One can overcome this issue of syrup viscosity by increasing it with an external agent. It is ideal to add small quantities of CMC, HPMC, or HPC in the syrup.
- In contrast, if the viscosity of syrup is high, there would be an issue with the pouring of the syrup out of the bottle. Thus, it is indispensable for the syrup manufacturers to maintain the optimal range of viscosity of syrup.
Critical physical features of syrup – What defines the visual attributes of pharma syrup? It is similar to other syrup products used elsewhere.
- Its appearance should be perfect, with no crystallization and microbial growth
- The color must be soluble with the rest of the ingredients.
- The odor and taste must be palatable. Thus, people use flavors in the pharma syrup.
Other tests that matter significantly – One can say that the viscosity is critical for all syrup products. Other tests are equally effective and essential.
1. Clean and purified vehicle (Distillation)
2. Light transmittance test
3. Visual inspection
4. pH measurement
5. Physical stability
6. Sucrose concentration (Assay of Active ingredient)
7. Refractive index
8. Specific gravity
9. Identification of Active ingredient
10. Optical rotation
11. Weight/ml (Density)
13. Alcohol determination (For Elixirs)
Essentiality of pharmaceutical packaging for liquid drugs
- Checking the uniformity – Medication and pharmaceutical products are here to help patients n healing and prevent health threats. Consuming the doses in high volume may harm you. These get made with substances and chemicals with specific functionality. Hence, pharmaceutical packaging manufacturers develop materials that prevent leaking and spilling. The packaging safeguards the active components in the medicines.
- Quality and information – Medical drugs do not have a long shelf life. Some of these products can expire in a year or more. The proper packaging of the material is critical for optimal function. in ensuring its quality for as long as it is useful. The drug’s effectiveness and potency may reduce.
- Prevention and precaution – Preventing medical drugs from a kid and ensuring a protective environment for the team and family members. It also prevents unnecessary chances of contamination and misuse. Unsafe handling or wrong information about the medical components may lead to dangerous circumstances. Thus, it is vital to pack correctly. It is also part of the safety and QC drills for a pharmaceutical company. If the company does not focus on these critical aspects, it may ruin their reputation
Professional testing and packaging – Both are equally critical.
In the pharma industry, one needs to find a reliable solution for drug manufacturing and packaging. From syrup development to storage – one cannot neglect anything. The lab testing facilities facilitate the process of finding accurate info and ease the needs. Connect to IRCLASS Systems and Solutions Pvt Ltd (ISSPL) laboratory for state-of-the-art quality checking facilities for pharmaceutical syrup, drugs, and more.