Jabatan Kemajuan Islam Malaysia, JAKIM, is the body entrusted with the issuance of the halal certificate. JAKIM can get the involvement of the religious bodies in the respective state to handle the request for halal certification. In the state of Pahang, representatives from Jabatan Agama Islam Pahang (JAIP) may audit product in the Notification category such as hand sanitisers. Due to worldwide distribution of halal products, JAKIM has
endorsed selected foreign halal approving bodies that provide halal certification e.g. Australian Federation of Islamic Councils Inc. without doubt. MS2424:2012 7 HALAL CERTIFICATION MARK - HALAL LOGO Reference/Certificate number for the halal product Guideline used for the manufacturing process
The approved halal logo issued by JAKIM with the manufacturing standard used and the certificate number to be positioned beneath the logo PHM2292 Nutraceuticals - Product Development 6 PHM2292 Nutraceuticals - Product Development 7
SOURCE OF RAW MATERIALS Traditional use PHM2292 Nutraceuticals - Product Development 8 PLANT MATERIALS PHM2292 Nutraceuticals - Product Development 9
NATURE OF ACTIVE INGREDIENTS PHM2292 Nutraceuticals - Product Development 10 COMPOUND - ARBORINE PHM2292 Nutraceuticals - Product Development 11
Which Dosage Form? PHM2292 Nutraceuticals - Product Development 12 PREFORMULATION TESTS Organoleptic properties Purity of API and excipients Analytical method Solubility Hygroscopicity
Ionization/dissociation constant (pKa) Partition coefficient (Log P) Dissolution behaviour Crystallinity and polymorphism Particle size, shape and surface area Bulk density Powder flow property Pearmeability Stability Drug-excipient compatibility PHM2292 Nutraceuticals - Product Development
13 EXCIPIENTS PHM2292 Nutraceuticals - Product Development 14 DILUENT OR FILLER PHM2292 Nutraceuticals - Product Development
15 LACTOSE: FILLER PHM2292 Nutraceuticals - Product Development 16 BINDER PHM2292 Nutraceuticals - Product Development
17 DISINTEGRANT PHM2292 Nutraceuticals - Product Development 18 GLIDANT, LUBRICANT AND ANTI-ADHERENT PHM2292 Nutraceuticals - Product Development
19 TABLET FORMULATION Material Dried leaves/Crude extract Lactose PVP Starch Talc Aerosil TOTAL Composition (% w/w) 10
40 10 20 10 10 100 PHM2292 Nutraceuticals - Product Development 20 CAPSULATION Material
Sodium starch glycolate 10 TOTAL 100 PHM2292 Nutraceuticals - Product Development 21
TABLETTING PHM2292 Nutraceuticals - Product Development 22 TYPES OF CAPSULES PHM2292 Nutraceuticals - Product Development 23
CAPSULATION PHM2292 Nutraceuticals - Product Development 24 ISSUES Is there a quality issue? Adulteration? Is there an efficacy issue? PHM2292 Nutraceuticals - Product Development
25 GUIDELINES ON SPECIFICATIONS NPR DEPARTMENT, MALAYSIA 1. Heavy metal analyses: a. Mercury: max. 0.5 ppm b. Arsenic: max. 5.0 ppm c. Lead: max. 10 ppm 2. Microbial contamination results 3. Disintegration test (for tablets and capsules only) PHM2292 Nutraceuticals - Product Development
26 ISSUE 1: HEAVY METAL CONTAMINATION Not uncommon for traditional products (Chan, 2003; Ting et al., 2013). Plants and herbs may have carryover of heavy metals from the soil. Heavy metal content due to contamination of fishes in many seas due to mercury is a concern. So, is fish oil safe? Chan, K. (2003). Some aspects of toxic contaminants in herbal
medicines.Chemosphere 52(9), 1361-71. Ting, A, Chow, Y & Tan, W. (2013).Microbial and heavy metal contamination in commonly consumed traditional Chinese herbal medicines. J Tradit Chin Med. 33(1),119-24. Posadzki, P., Watson, L. & Ernst, E. (2013). Contamination and adulteration of herbal medicinal products. Eur J Clin Pharmacol. 69 (3), 295-307. doi: 10.1007/s00228-012-1353-z. Epub 2012 Jul 29. PHM2292 Nutraceuticals - Product Development 27 SOME EXAMPLES OF NMP FROM OKUNLOLA ET AL. (2007) Dosage form
Reference: Adenike Okunlola, Babatunde A. Adewoyin and Oluwatoyin A. Odeku. Evaluation of Pharmaceutical and Microbial Qualities of Some Herbal Medicinal Products in South Western Nigeria. Tropical Journal of Pharmaceutical Research, March 2007; 6 (1): 661-670. Retrieved March 13, 2015 from http://www.tjpr.org PHM2292 Nutraceuticals - Product Development 28 FINDINGS BY OKUNLOLA ET AL. (2007)
Twelve (57.1%) of the products had their manufacturing and expiry dates stated, Nine (42.9%) products have been registered by NAFDAC Ten (47.6%) did not have their content stated but had their therapeutic claims indicated on the container. The tablet formulation (Product A) showed acceptable crushing strength and friability but failed the test for disintegration time. The angle of repose of the powder dosage forms were considerably high showing that the powders were highly cohesive and not free flowing.
The microbial load of the products varied considerably. Ten (47.6%) of the samples were contaminated by E. coli, seven (33%) were contaminated by Salmonella, fifteen (71.4%) were contaminated by Staphylococcus aureus and twelve (57.1%) were contaminated by fungi. PHM2292 Nutraceuticals - Product Development
29 FINDINGS BY GUPTA ET AL. (2012) 20 herbal products as tablet, powder and capsule were evaluated Isolation and identification of microbial contamination showed that all samples were contaminated with Salmonella sp. Reference: DK Gupta, RD Sharma, R Gupta, S Tyagi, KK Sharma (2012), Evaluation of Some Herbal Solid Dosage Forms for Microbial Contamination, Int J PharmPharm Sci, Vol 4, Suppl 4, 261-263 PHM2292 Nutraceuticals - Product
Development 30 ADULTERATION Adulteration refers to the accidental or intentional addition or substitution or dilution of a material with an ingredient (not disclosed, lower-cost) PHM2292 Nutraceuticals - Product Development 31
ADULTERATION OF HERBAL PRODUCTS Posadzki, P., Watson, L. & Ernst, E. (2013). PURPOSE: To summarise and critically evaluate the evidence from systematic reviews. METHODS: Five electronic databases were searched to identify all relevant systematic reviews. RESULTS: Twenty-six systematic reviews. The most commonly HMPs were adulterated or contaminated with dust, pollens, insects, rodents, parasites, microbes, fungi, mould, toxins, pesticides, toxic heavy metals and/or prescription drugs. The most severe adverse effects caused by these adulterations were agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral
edema, coma, intracerebral haemorrhage, and death. Adulteration and contamination of HMPs were most commonly noted for traditional Indian and Chinese remedies, respectively. CONCLUSIONS: More stringent quality control andPHM2292 its enforcement seem to be necessary to avoid health Nutraceuticals - Product 32 risks. Development ISSUE 2: PHARMACOKINETIC AND BIOAVAILABILITY Evidence-based verification of efficacy
Analytical data for bioavailability elucidation of metabolic pathways (yielding potentially new active compounds), and the assessment of elimination routes and their kinetics. Interaction with synthetically-derived drug Reference: Bhattaram VA, Graefe U, Kohlert C, Veit M, Derendorf H. Pharmacokinetics and bioavailability of herbal medicinal products. Phytomedicine. 2002;9 Suppl 3:1-33. Review. PubMed PMID: 12222652. PHM2292 Nutraceuticals - Product Development 33
CONCLUSION * Action plan http:// cms.herbalgram.org/press/2014/GA_Endorses_Adulterants_Program.html?ts=1402895334&signature= 9ce756077e36d05afbf3fa106057d344 PHM2292 Nutraceuticals - Product Development 34 Exercise Identify the nutritional benefits of the following items and discuss with your BFF on
the best dosage form: Ketum Petai Peria PHM2292 Nutraceuticals - Product Development 35
Tanah Milik Mana-mana tanah termasuk mana-mana petak bangunan yang pecah sempadan, yang telah didaftarkan hakmilik sama ada tetap atau sementara, sama ada untuk selama-lamanya atau bertempoh berapa tahun, dan sama ada diberi milik di bawah Akta Kanun Tanah Negara atau...
Informatics projects in support of the CFP and ecosystem based management. Review of conservation benefits for the Biological Sensitive Area (BSA, Council Regulation (EC) No 1954/2003) Studies to support spatial or other measures for fisheries management and protection of biodiversity....
exception to minimum size - every door direct mail -length 10-1/2 inches ***** flats cannot be too rigid and must be uniformly thick (within ¼") what you need to know about mailpiece design processing category your mailpiece is a parcel...
You get sick and need to go see your primary care doctor. Your primary care doctor diagnoses you with the flu and prescribes you some medication. You go to the pharmacist to pick up your medication. What questions might you...
payoff table shows the gain (positive or negative) for player 1 that would result . from each combination of strategies for the two players. A primary objective of game theory is the development of rational criteria for selecting a strategy....
Your Comparison (1): "Days" "Because I could not stop for death" 1. "Because I could not stop for death" describes death as a more optimistic way. She thinks that we can't avoid the process of death, so we should accept...
Ready to download the document? Go ahead and hit continue!